Medical Devices

ISO 13485 For Medical Devices Manufacturing

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

Continuous innovation is key to the advancement of medical device technology. To allow for innovation, whilst also assuring safety and effectiveness, global standards are required. This article provides information for companies manufacturing medical devices on the benefits of holding ISO 13485 certification and how to get certified.

While ISO 13485:2016 remains a stand-alone document, it aligns with ISO 9001:2008. (Yes, 2008, not 2015.)  This is because it does not follow the high-level structure (Annex L) of the latest version of ISO 9001 (which is 9001:2015). In addition, the documentation and safety requirements are much greater under ISO 13485:2016, whereas ISO 9001:2015 puts focus on customer satisfaction and continuous improvement.

This global standard is mandatory in some countries, and in the U.S. the FDA has proposed a rule which would harmonize U.S. FDA 21 CFR 820 with ISO 13485:2016, making ISO 13485 the FDA’s mandatory QMS for Medical Devices (the rule is expected to be released in 2019).  In the meantime, the medical device industry can rely on AAMI TIR102:2019, which is a bi-directional mapping tool that was released on August 30, 2019.

Medical support

Organizations involved in one or more stages of the medical device Lifecyle

  • Design and Development
  • Production
  • Storage
  • Distribution
  • Installation
  • Servicing

    Suppliers or External Parties who provide products to such Organizations

  • Raw materials
  • Components
  • Sub-assemblies
  • Medical devices
  • Sterilization services
  • Calibration services
  • Distribution services
  • Maintenance services

Our experts are available on the following International standards for the mentioned countries:

1. ISO 9000 – Quality Management; 2. ISO / IEC 27000 – Information Security Management Systems; 3. ISO 14000 – Environmental Management; 4. ISO 31000 – Risk Management; 5. ISO 50001 – Energy Management; 6. ISO 26000 – Social Responsibility; 7. ISO 28000: 2007 – Specifications for Security Management Systems for the Supply Chain; 8. ISO 37001: 2016 Anti-Bribery Management Systems; 9. ISO 45001 – Occupational Health and Safety; 10. ISO 22000 – Food Management Systems, HACCP, CE MARK, CMMI, HALAL, GDPR

Afghanistan, Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Armenia, Australia, Austria, Austrian Empire, Azerbaijan, Baden*, Bahamas, The Bahrain, Bangladesh, Barbados, Bavaria*, Belarus, Belgium, Belize, Benin (Dahomey), Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Brunswick and Luneburg, Bulgaria, Burkina Faso (Upper Volta), Burma, Burundi, Cabo Verde, Cambodia, Cameroon , Canada, Cayman Islands, The Central African Republic, Central American Federation*, Chad, Chile, China, Colombia, Comoros, Congo Free State, The Costa Rica, Cote d’Ivoire (Ivory Coast),  Croatia, Cuba, Cyprus,  Czechia, Czechoslovakia, Democratic Republic of the Congo,  Denmark, Djibouti, Dominica, Dominican Republic, Duchy of Parma, East Germany (German Democratic Republic),  Ecuador, Egypt, El Salvador,  Equatorial Guinea, Eritrea, Estonia, Eswatini, Ethiopia, Federal Government of Germany (1848-49)*,Fiji, Finland, France, Gabon, Gambia, The Georgia, Germany, Ghana, Grand Duchy of Tuscany, The*, Greece, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Hanover*, Hanseatic Republics*, Hawaii*, Hesse*, Holy See, Honduras, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kingdom of Serbia/Yugoslavia*, Kiribati, Korea, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Lesotho, Lew Chew (Lochia)*, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Mauritania, Mauritius, Mecklenburg-Schwerin*, Mecklenburg-Strelitz*, Mexico, Micronesia, Moldova, Monaco, Mongolia, Montenegro, Morocco, Mozambique, Namibia, Nassau*, Nauru, Nepal, Netherlands, New Zealand, Nicaragua, Niger, Nigeria, North German Confederation*, North German Union*, North Macedonia, Norway, Oldenburg*, Oman, Orange Free State*, Pakistan, Palau, Panama, Papal States*, Papua New Guinea, Paraguay, Peru, Philippines, Piedmont-Sardinia*, Poland, Portugal, Qatar, Republic of Genoa*, Republic of Korea (South Korea), Republic of the Congo, Romania, Russia, Rwanda, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Samoa, San Marino, Sao Tome and Principe, Saudi Arabia, Schaumburg-Lippe*Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, South Sudan, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Syria, Tajikistan, Tanzania, Texas*, Thailand, Timor-Leste, Togo, Tonga, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Tuvalu, Two Sicklies*, Uganda, Ukraine, Union of Soviet Socialist Republics*, United Arab Emirates,  United Kingdom, Uruguay, Uzbekistan, Vanuatu, Venezuela, Vietnam, Württemberg*, Yemen, Zambia, Zimbabwe

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