ISO 13485

ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). ISO 13485:2016 Certificates meets the requirement of IEC 60601-2-25 : 1993 + A1: 1999 safety of Electrocardiograms.

The current ISO 13485 effective edition was published on 1 March 2016.[1]


Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration.[2]

Reason for use

While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.[3]

Other specific differences include:

  • the promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U.S. Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union
  • controls in the work environment to ensure product safety
  • focus on risk management activities and design control activities during product development
  • specific requirements for inspection and traceability for implantable devices
  • specific requirements for documentation and validation of processes for sterile medical devices
  • specific requirements for verification of the effectiveness of corrective and preventive actions

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Directives 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. One of the major requirements to prove conformity is the implementation of the Quality Management System according ISO 9001 and/or ISO 13485 and ISO 14971.[4] Although the European Union Directives do not mandate certification to ISO 9001 and/or ISO 13485 the preferred method to prove compliance to such standards is to seek its official certification which is issued by certifying organizations known as "Registrars". Several registrars also act as Notified Body. For those medical devices requiring the pre-market involvement of a Notified Body, the result of a positive assessment from the Notified Body is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union. A very careful assessment of the company Quality Management System by the Notified Body, together with the review of the required Technical Documentation, is a major element which the Notified Body takes into account to issue the certificate of conformity to the company product(s).

This standard adopted by CEN as EN ISO 13485:2003/AC:2007 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC.[5]

ISO 13485 is now considered to be inline standard and requirement for medical devices even with "Global Harmonization Task Force Guidelines" (GHTF).[6] The GHTF guidelines are slowly becoming universal standards for design, manufacture, export and sales of various medical devices. The GHTF has been replaced in the last few years by the International Medical Device Regulatory Forum (IMDRF)[7] and is structured differently from the GHTF as only the regulators, that are primary members of the group, get to make many of the decisions. The IMDRF main membership (the regulators) do want to have non-regulators involved without voting rights and in this way they are hoping to get the process and documents completed quicker than under the GHTF system (regulators & non-regulators were equal in voting rights) that worked reasonably well, but somewhat slow.

This standard adopted by CEN as EN ISO 13485:2012 is harmonized with respect to the European Medical Devices Directive 93/42/EEC.[8]

Mexico has published in October 11, 2012 a national standard as a Norma Oficial Mexicana (NOM) to control manufacture of medical devices inside the country. NOM-241-SSA1-2012, Buenas Practicas de Fabricación para Establecimientos dedicados a la Fabricación de Dispositivos Médicos.[9] The scope of application is mandatory in the national territory, for all establishments dedicated to the process of medical devices marketed in the country. The Cofepris is the body assigned to its control, verification and to grant the records of compliance to the companies that implement this Standard of Good Manufacturing Practices. This standard is partially in line with ISO 13485: 2003 and ISO 9001: 2008.

In 2017, The Farmacopea de los Estados Unidos Mexicanos (United Mexican States Pharmacopoeia), medical industrial sectors and Cofepris are working together for updating NOM-241 Standard, putting special attention on manage of risks during manufacture and regulating by manufacturing lines some of the most important medical devices manufacturing processes. This standard will be published in August 2018, and 180 days after publication it will become mandatory for the industry.

In Spain, medical devices are named in ISO-13485 as "Sanitary Products" as Castellano-language translation of ISO-13485, but in Mexico they are known as "Medical Devices" and correspond to those used in medical practice and that meet the definition established by NOM-241 as: Medical device, to the substance, mixture of substances, material, apparatus or instrument (including the computer program necessary for its proper use or application), used alone or in combination in the diagnosis, monitoring or prevention of human or auxiliary diseases in the treatment of the same and of the disability, as well as the employees in the replacement, correction, restoration or modification of the anatomy or human physiological processes. Medical devices include products of the following categories: medical equipment, prostheses, orthotics, functional aids, diagnostic agents, supplies for dental use, surgical, healing and hygiene products. ISO 13485:2016 Certificates meets the requirement of IEC 60601-2-25 : 1993 + A1: 1999 safety of Electrocardiograms.

See also


  1. ^ "ISO 13485:2016 - Medical devices -- Quality management systems -- Requirements for regulatory purposes". Retrieved 2016-03-24.
  2. ^ "IATF 16949:2016 Automotive Quality Management System - BSI America - BSI America".
  3. ^ "Understanding ISO 13485".
  4. ^ "ISO 9001".
  5. ^ "Summary list of titles and references of harmonised standards related to medical devices - DG Enterprise & Industry. European Commission". Archived from the original on 2009-02-01.
  6. ^ "GHTF is no longer in operation".
  7. ^ "International Medical Device Regulators Forum".
  8. ^ "CENELEC - Standards Development - List of Technical Bodies -".
  9. ^ "NORMA Oficial Mexicana NOM-241-SSA1-2012, Buenas prácticas de fabricación para establecimientos dedicados a la fabricación de dispositivos médicos". Retrieved 19 October 2017.

External links


AAEON Technology Inc. was first founded in 1992 in Taiwan. and has expanded globally since, establishing offices in United States, China, Singapore, Germany and the Netherlands. AAEON manufactures and markets a wide range of OEM/ODM industrial PCs worldwide. Its product lines include Embedded Boards & Computer On Module, Applied Computing & Network Appliances, All-in-One HMI Systems & Displays, Digital Signage & Self-Service Kiosk as well as Cloud Computing. In collaboration with manufacturers and vendors such as Seagate, Blue Chip Technology and Sequans, Many of its products are applied in industries such as Machine and Factory Automation, Chemical, Medical, Finance, Education, Transportation. In addition, Digital Signage and Kiosk applications are more prevalent in recent years.Headquartered in Taipei, Taiwan, AAEON has obtained many certifications throughout the years. It received the ISO-9001 certification and the ISO-14001 certification in 1994 and 1997, respectively. AAEON was awarded the TL9000 certification in 2002 and the ISO 13485 Medical certification in 2007. In addition to numerous awards from Intel and Siemens, they have been the recipient of the Taiwan Symbol of Excellence Award for the past 6 years. In 2000, AAEON acquired Astech Technology, Inc as part of its Panel PC Division. AAEON became a public limited company on the Taiwan Stock Exchange in 2001 under TAIEX: 2463. AAEON was removed from the TSE after joining AsusTek Computer Inc. (ASUS) in 2011.

Cedarlane Laboratories

Cedarlane is a Canadian private corporation headquartered in Burlington, Ontario, Canada, that manufactures and distributes life science research products. Cedarlane's manufactured products include monoclonal antibodies, polyclonal antibodies, cell separation media, complement for tissue typing, and immunocolumns. Cedarlane is an ISO 9001:2008 and ISO 13485:2003 registered company. Cedarlane has become a multi-national corporation with over 100 employees in Canada and the United States. The two main locations are in Burlington, Ontario, Canada and coincidentally, in Burlington, North Carolina, US.In recent years, Cedarlane has partnered with a number of charitable Canadian organizations to raise funding for cancer research, economically impoverished children, men's health initiatives and much more. Cedarlane has partnered with the likes of the Canadian Cancer Society, Canadian Breast Cancer Foundation, SickKids Foundation, and others.

In 2017, Cedarlane will celebrate its 60th anniversary after being founded in 1957 by Richard Course.

Cerilliant Corporation

Cerilliant Corporation, located in Round Rock, Texas, is a manufacturer of certified reference standards and certified reference materials providing products and services to forensic / toxicology, diagnostic/clinical, environmental, natural products, and pharmaceutical industries. Cerilliant is accredited to ISO Guide 34 & ISO/IEC 17025 and certified to ISO 13485 and ISO 9001:2008.Formerly known as the Analytical Reference Materials Division of Radian International, Cerilliant was founded in 1980 and began producing chemical reference standards to address the needs of the emerging environmental testing industry. The company was the first to produce 13C labeled chlorinated dioxins and furans in cooperation with Cambridge Isotope Laboratories. Cerilliant innovated Snap-N-Shoot ready-to-use reference standards in solution, pioneered DEA-exempt preparations of controlled substances in solution, was the first to offer certified isotope-labeled drug reference standards, and the first to develop critical metabolites, impurities, and degradants of certain drugs and environmental contaminants. In 2000, Radian's parent, URS Corporation, made the decision to divest the division. Cerilliant was formed following the purchase of the division by private investors.

Cerilliant provides catalog and custom products and services including Certified Solution Standards, Certified Spiking Solutions, custom organic synthesis of neat reference materials as well as independent analytical certifications and custom packaging of client reference standards.

Catalog products include Drugs-of-Abuse, Pharmaceuticals, Drug Metabolites and Impurities, P450 metabolites, Glucuronides, Benzodiazepines, Opiates, Steroids, Amphetamines, Drug Mixes, Nitroglycerins/ Explosives, Chemical Warfare by-products, and Phytochemicals. Custom services include synthesis of drug substances, metabolites, impurities, and degradants (including stable isotope-labeled compounds), analytical certifications, custom packaging of all types of materials (single-use or bulk), and custom standard dilutions of single or multi-component mixes.Cerilliant was acquired by Sigma-Aldrich Co. in 2011.

College Park Industries

College Park Industries is a prosthetics manufacturer headquartered in Warren, Michigan. The company was founded in 1988 after a local machinist set out to create the world’s most anatomically correct prosthetic foot.College Park’s first product was the Trustep® foot, which mimics the anatomical movement of a foot by replicating the bones and tendons through composites, bumpers and bushings. Since the release of the Trustep®, College Park has gone on to design and develop many other innovative prosthetic feet that utilize their proprietary Intelliweave™ composites. These include the Truper®, the first multi-axial pediatric foot; the Soleus®, which was the first to incorporate Integrated Spring Technology (iST™); the heel-height adjustable Accent® foot; and the Odyssey® K2 & Odyssey® K3 feet which have a patented curved hydraulic ankle. College Park also manufacturers other prosthetic products, including endoskeleton components, liners, and sleeves. The company is ISO 13485 certified and sells its products worldwide. In 2015, College Park acquired Liberating Technologies, Inc., an upper-limb prosthetics company.

Dental laboratory

Dental laboratories manufacture or customize a variety of products to assist in the provision of oral health care by a licensed dentist. These products include crowns, bridges, dentures and other dental products. Dental lab technicians follow a prescription from a licensed dentist when manufacturing these items, which include prosthetic devices (such as denture teeth and implants) and therapeutic devices (such as orthodontic devices). The FDA regulates these products as medical devices and they are therefore subject to FDA’s good manufacturing practice ("GMP") and quality system ("QS") requirements. In most cases, however, they are exempt from manufacturer registration requirements. Some of the most common restorations manufactured include crowns, bridges, dentures, and dental implants. Dental implants is one of the most advanced dental technologies in the field of dentistry.

Certification in the dental laboratory profession is strictly voluntary. Laboratories who have taken the extra steps to become certified represent the top of their field. The most easily obtainable certification is the CDL (Certified Dental Laboratory). A Certified Dental Laboratory has met standards in personnel skill, training, infection control, tracking mechanisms and good business and manufacturing practices. The certification is based on a third party review of photos of the facility. The next tier for certification is DAMAS (Dental Appliance Manufacturers Audit Scheme). DAMAS requires a third party on-site inspection. Based on international standards for the manufacturing of medical devices, the DAMAS certification ensures the lab environment operates in such a way as to ensure product and patient safety. It provides a formula for improved documentation of many aspects of dental lab activity (from dental prescriptions to material traceability). DAMAS standards mirror the FDA's quality system and good manufacturing practice standards, which all domestic dental laboratories must comply with.The highest level of manufacturing certifications available to dental laboratories are through the ISO "International Organization for Standardization". The ISO develops standards through the consensus of standards organizations from 161 countries. Members represent both the public and private sectors of countries around the world. ISO standards are thought to represent the best interests and needs of the broader global society. ISO 9001 is a set of standards for quality management systems. ISO 13485 is a set of standards, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. It emphasizes meeting regulatory requirements and managing risk in order to ensure the production of safe design and distribution of medical devices. Product documention is thorough and covers the entire life cycle of product design, manufacture and post-delivery. Although not considered a substitute, ISO 13485 will align a dental lab's management system not only with the FDA QS-GMP regulation, but various other regulatory requirements found throughout the world.


Eurogentec is an international biotechnology supplier, based in Belgium, that specializes in genomics and proteomics kits and reagents as well as cGMP biologics. The company was founded in 1985 as a spin-off from the University of Liège. Eurogentec's contract manufacturing organization facilities are licensed by the Belgian Ministry of Health to produce clinical trial and commercial biopharmaceutical material and also licensed by the US FDA to manufacture a commercial recombinant protein product for the US market. Eurogentec operates two manufacturing facilities in Belgium that provide custom biologics and oligonucleotide-based components for diagnostic and therapeutic/prophylactic applications.


Fermentek Ltd. is a biotechnological company in the Atarot industrial zone of Jerusalem, Israel. It specializes in the research, development and manufacture of biologically active, natural products isolated from microorganisms as well as from other natural sources such as plants and algae.

The main microorganisms used are nonpathogenic actinomycetes, Nocardia and Streptomycetes. The fungi used are: Penicillium, Aspergillus, Fusarium and the like. None of these is a human pathogen.

Fermentek does not sell to individuals. Most of its products are marketed through major international distributors specializing in chemicals, under their own brand names. Nevertheless, Fermentek has specific impact on the biochemical market, especially in the field of mycotoxins.

Mycotoxins are toxic compounds produced by molds in human food and farm animal feeds, thus being economically important factors. Fermentek manufactures an extensive line of pure mycotoxins used as standards in food analysis. In some cases, such as Aflatoxin M2, Fermentek supplies the entire world's requirements.In 2009 Fermentek announced a product family of highly standardized calibrant solutions of main mycotoxins. These are marketed under the brand name FermaSol. In 2010 it obtained ISO 13485 accreditation in connection with the production of starting materials for experimental drug production, and with manufacturing of reference standards of food contaminants.

None of Fermentek's products have been invented by it. Fermentek's aim is to make known compounds affordable to the scientific community.

Fermentek was founded by Dr Yosef Behrend in 1994. It moved in 2004 to its new building, quadrupling its working space and greatly enlarging its manufacturing capacities.

Fischer Connectors

Fischer Connectors designs, manufactures and distributes electrical and optical connectors, cable assemblies and connectivity systems and manufactures a range of circular push–pull connectors. Fischer Connectors’ circular push–pull connectors, electrical and optical cable assembly solutions, and integrated systems are used in aerospace, broadcast, defense, energy, food, industrial, instrumentation, marine, medical, nuclear, oil and gas, pharmaceutical, robotics, security, transportation and vacuum applications.

Founded in 1954, the headquarters and manufacturing facility is based in St-Prex, Switzerland, with cable assembly facilities in Europe, North America and Asia Pacific, and subsidiaries and distributors worldwide. Fischer Connectors’ circular push-pull connectors and cable assembly solutions – both electrical and optical – are used in numerous applications.

Fisher Connectors comply with international quality standards, including ISO 9001, ISO 13485, ISO 14001, OHSAS 18001, REACH and ROHS.


Foster-Miller, Inc., is a United States-based military robotics manufacturer, a division of the United Kingdom's Qinetiq North America. Its two best-known products are TALON robots and LAST Armor.

Founded and based in Waltham, Massachusetts, it has offices in Washington, D.C., Albany, New York, and near Boston. Foster-Miller became a wholly owned subsidiary of Qinetiq in 2004.

Foster-Miller has about 300 members of staff skilled in aeronautical engineering, administration, chemical engineering, chemistry, physics, civil engineering, electrical engineering, mathematics, statistics, mechanical engineering, metallurgy, polymers, polymerization, electromechanical engineering.

Foster-Miller works in the fields of robotics, advanced materials, sensors, custom machinery, medical device design, biopharmaceuticals, C4ISR and transportation. It has been awarded the aerospace quality management standard AS9100 (6 January 2006) and SW-CMM Level 3 software certification (9 February 2006) and ISO 13485 for medical device design and development.

Gauthier Biomedical

Gauthier Biomedical, based in Grafton, Wisconsin, designs and manufactures spinal and orthopedic surgical instruments for OEM (original equipment manufacturers) in the United States and foreign countries.

Gauthier Biomedical was founded in 2000 by Michael Gauthier who is acting president of the company. Michael and his wife Stacy Gauthier, vice president of Gauthier Biomedical, both attended Marquette University located in Milwaukee, Wisconsin. Gauthier Biomedical works with all grades of stainless steel, aluminum alloys, plastics, phenolic, and silicone. They are ISO 13485:2003 certified. Gauthier Biomedical is the owner of several patents in medical device technology including the No Play ratcheting mechanism which limits axial and side-to-side “play” or “wobble” between shaft and handle (Protected by US Patent Numbers 6,817,458; 6,948,605; 7,014,023; 7,156,216; 7,413,065; and other patents pending).

ISO 14971

ISO 14971 is an ISO standard for the application of risk management to medical devices. The ISO Technical Committee responsible for the maintenance of this standard is ISO TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51, and ISO/IEC Guide 63. The latest significant revision was published in 2007 with a minor update published in 2009. In 2013, a technical report ISO/TR 24971 was published by ISO TC 210 to provide expert guidance on the application of this standard.

This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality management system standards such as ISO 13485. Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and management, and also specifies a procedure for review and monitoring during production and post-production.In 2012, a European harmonized version of this standard was adopted by CEN as EN ISO 14971:2012. This version is harmonized with respect to the three European Directives associated with medical devices Active Implantable Medical Device Directive 90/385/EEC, Medical Devices Directive 93/42/EEC, and In-vitro Diagnostic Medical Device Directive 98/79/EC, through the three 'Zed' Annexes (ZA, ZB & ZC). This was done to address the presumed compliance with the 3 Directives that is obtained through notified body certification audits and regulatory submissions that claim compliance to this standard.EN ISO 14971:2012 applies only to manufacturers with devices intended for the European market; for the rest of the world, ISO 14971:2007 remains the standard recommended for medical device risk management purposes.

Kossan Rubber Industries

Kossan Rubber Industries is a Kuala Lumpur based public limited company engaged in manufacture, sale, and export of rubber products. It was founded by Dato’ Lim Kuang Sia in 1979.

Medical device

A medical device is any device intended to be used for medical purposes. Thus what differentiates a medical device from an everyday device is its intended use. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938 that medical devices were regulated. Later in 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States. Medical device regulation in Europe as we know it today came into effect in the 1993 by what is collectively know as the Medical Device Directive (MDD). On May 26th, 2017 the Medical Device Regulation (MDR) replaced the MDD.

Medical devices vary in both their intended use and indications for use. Examples range from simple, low-risk devices such as tongue depressors, medical thermometers, disposable gloves, and bedpans to complex, high-risk devices that are implanted and sustain life. One example of high-risk devices are those with Embedded software such as pacemakers, and which assist in the conduct of medical testing, implants, and prostheses. Items as intricate as housings for cochlear implants are manufactured through the deep drawn and shallow drawn manufacturing processes. The design of medical devices constitutes a major segment of the field of biomedical engineering.

The global medical device market reached roughly $209 billion USD in 2006 and was estimated to be between $220 and $250 billion USD in 2013. The United States controls ~40% of the global market followed by Europe (25%), Japan (15%), and the rest of the world (20%). Although collectively Europe has a larger share, Japan has the second largest country market share. The largest market shares in Europe (in order of market share size) belong to Germany, Italy, France, and the United Kingdom. The rest of the world comprises regions like (in no particular order) Australia, Canada, China, India, and Iran. This article discusses what constitutes a medical device in these different regions and throughout the article these regions will be discussed in order of their global market share.

OSCAR McMaster

OSCAR McMaster is a web-based electronic medical record (EMR) system initially developed for academic primary care clinics. It has grown into a comprehensive EMR and billing system used by many doctor's offices and private medical clinics in Canada and other parts of the world. The name is derived from where it was created and an acronym; OSCAR stands for Open Source Clinical Application and Resource and McMaster refers to McMaster University, where it was developed. It enables the delivery of evidence resources at the point of care.

Since December 1, 2005, OSCAR McMaster had received successive certifications by OntarioMD under the Physician IT Program. OSCAR McMaster version 15 has also achieved ISO 13485:2003 certification, and has met the requirements of the latest OntarioMD Specification 4.1A. On September 30, 2012, OSCAR McMaster v12 product received Pre-implementation Certification for Jurisdiction Class, Laboratory and Clinical Documents, Electronic Medical Record. As of May 3, 2016, OSCAR is the only open-source Clinical Management System (CMS) product (out of a list of fourteen certified products from ten vendors) to meet/exceed the requirements that ensure the product supports defined standards for clinical and practice management software and is currently holding twenty percent of the market share.

Product Development Technologies

Product Development Technologies, Inc. is a global product development consultancy founded in 1995. PDT is headquartered in Lake Zurich, Illinois, United States, with regional studios in Austin, Chicago, Fort Lauderdale, Los Angeles and Minneapolis. The company maintains an international presence in the United Kingdom, Ukraine and China.PDT works in these various disciplines: product strategy, design research, industrial design, user experience, mechanical engineering, electrical engineering, software development, prototyping, quality assurance and global sourcing. The company specializes in the development of new products within the medical, consumer and defense sectors. Product Development Technologies is ISO 9001:2008, ISO 13485 certified and ITAR registered. In 2000, Inc. Magazine named PDT as the 22nd fastest growing company in the United States.The PDT portfolio includes projects with clients including: Motorola, Dell, Qualcomm, Iridium, Texas Instruments and Cardinal Health. In 2011, PDT announced its partnership with a major U.S. university and Dr. Peter Belafsky, M.D., M.P.H., Ph.D. to create a new swallow enhancement device for sufferers of dysphagia. In 2009, PDT was also selected to work with Copenhagen-based Æsir, developing the Æ+Y mobile phone concepted by international designer Yves Béhar. After more than 7,000 hours of engineering, the phone launched in 2011. The firm also earned a 2010 Good Design Award for its work on the Invitrogen MAGic Sample Processor.

Technical file

A technical file is a set of documents that describes a product and can prove that the product was designed and according to the requirements of a quality management system.

All products that have a CE mark must have a technical file which must contain the information that proves that the product conforms with the EU directives for CE-marked products. EU enforcement authorities may demand a copy of the technical file for many years after the last product was made. Customers do not usually have access to the technical file.

A technical file is usually based on a document archive system that ensures longevity of documents and can either be on paper or in electronic files. One document may be named "technical file" and list all other documents that are considered part of the technical file.

A technical file includes drawings, specifications, reports, review records, meeting minutes, labels, instructions for use, software source code, etc.

The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of a medical device to establish a technical file (medical device file).

Topflight Corporation

Topflight Corporation is a manufacturer of printed labels and die-cut components. Topflight is ISO 9001:2008 and ISO 13485:2003 certified and is one of the oldest privately owned label companies. Topflight creates products for varying industries: Medical Devices, Pharmaceutical, Consumer & Durable Goods, Cosmetic & Personal Care, Electronics, Tire and Automotive. Based on annual sales of printed and converted labels, Topflight is ranked number 21 on the Top Tag and Label Converters list.

Trend Technologies

Trend Technologies (formerly called Data Packaging) is an international manufacturer specialising in plastic injection molding with the first facility opening in Mullingar, Ireland in 1985. The company serves the automotive, healthcare, ICT and industrial sectors. The company's subsidiaries are the Cam Fran Tool and Die Company, Stevenson Grantech Limited and Tintarent Limited.

Volume Interactions Pte Ltd

Volume Interactions Pte Ltd was a company that pioneered in the 1990s the use of virtual surgery planning. This was done by means of its flagship product the Dextroscope, which used Virtual Reality technology (a two-handed 3D user interface, stereoscopic displays) to provide a natural interface to plan surgical approaches for patients using multi-modality 3D medical images. The company later introduced the Dextrobeam, a product designed to make 3D medical stereoscopic presentations to large audiences, using stereoscopic projection systems.The company Quality Management System complied with the requirements of ISO 13485:2003 and the products were listed in the Singapore Medical Device Registration (SMDR) by the Health Sciences Authority of Singapore.

The Dextroscope and Dextrobeam received USA FDA 510(K) - class II (2002) clearance, CE Marking - class I (2002), China SFDA Registration - class II (2004) and Taiwan Registration - type P (Radiology) (2007).

The company was a spin-off company from the Kent Ridge Digital Labs research institute in Singapore. The company was founded in 2000 in Singapore and acquired by the Bracco Group in 2002. Volume Interactions ceased commercial operations in 2008.

ISO standards by standard number

This page is based on a Wikipedia article written by authors (here).
Text is available under the CC BY-SA 3.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.