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What is ISO 13485?

ISO 13485 is an international standard which represents the requirements for a Quality Management System for companies which design and manufacture of Medical Devices.

It outlines the different aspects needed to be covered by the company’s QMS. Companies must apply this standard throughout their products’ life cycle, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.


It is recommended for a company to pursue ISO 13485 certification even before it begins manufacturing medical devices since certification is required by most international regulatory bodies, in particular the European regulatory requirements.

ISO 13485:2016

Published in May 2017, the In Vitro Diagnostic Regulation (2017/746) or “IVDR” is formally the definitive regulation governing the marketing of IVDs within the European Economic Area (EEA).  The regulation is based on a lifecycle approach and replaces the In Vitro Diagnostic Directive (IVDD 98/79/EC). 

The new IVDR comes into force in May 2022 and brings many changes.  It will employ a stricter oversight that will encompass many more products than the IVDD did. 

The IVDR brings in a new classification system and strengthened regulatory emphasis on clinical and performance data while elaborating guidance pertaining to post-market evaluations and vigilance efforts.

ISO 13485:2016 vs. 21 CFR Part 820

Many representatives from different countries have contributed to the construction of the ISO 13485, amongst whom are FDA personnel, especially in the latest revision (ISO 13485:2016).

The logic behind this cooperation is that it is easier to rely on a single standard than it is to try to comply to many.

Since FDA representatives helped formulate the ISO’s latest revision, the majority of the elements discussed in the 21 CFR Part 820 have been embedded into ISO 13485:2016

So what is the difference between the two?

TopicISO 13485:2016FDA 21 CFR Part 820
Legal statusHas no legal basis, however has a worldwide recognition

Has a legal status and is mandatory for Medical Devices distributed in the US
DistributionAn international standard used by many statesApplies only in the US but is also acknowledged by other countries as well.
Outside influenceA certification is issued by an external accredited bodyNo certification
AuditsAnnual surveillance audits, renewal audit every 3 years

Class II and Class III device manufacturers are inspected every two years
Quality System- ISO13485- Gemarmed

When is the right time to establish a QMS?

Many companies struggle with the question when is the right time to establish a QMS per ISO 13485 or QSR requirements. Many companies are reluctant to introduce a QMS since they are afraid it will hold back or slow down their progress, on the other hand if they introduce it too late it will lead to deficiencies in some processes and potential issues with regulatory authorities that can set back and cost even more time and money.

The answer is there is no ‘one-size-fit-all’, the following need to be considered:

  • What is the size of your organization?
  • What stage are you in the development process? Are you in the concept or research phase? Do you have a prototype? Are you thinking about going to a clinical trial?
  • What is your product? Is it a complex system or a simple solution?

Remember, you can start establishing a QMS based on the stage you are in at them moment. For example, document control or some design controls can be introduced in the development stage while customer complaints or even CAPAs can be introduced later on.

How can we help?

Since 2011, GEMARMED’s experts have been assisting Medical Device companies establish and maintain their QMS based on the 21 CFR Part 820 and ISO 13485 guidelines.

The process that we establish applies rules and regulation that help maintain the Plan-Do-Check-Act (PDCA) cycle and keep weigh its risk in accordance with the latest version.

In addition to internal audits that we perform, we have a team of professional medical device experts with experience in quality standards and regulatory compliance who can help you prepare for any audit.

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