ISO 13485 Medical Devices FAQ

ISO 13485 medical devices FAQ 

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Here are some ISO 13485 medical devices faq which might help you out with your queries.

Is ISO 13485 standards mandatory in India ?

A standard is not mandatory. But must say that in Europe, for Medical Device Companies, the ISO 13485 standard is recommended. Why? because to get a certified quality system, you need to find a Notified Body that will approve it.  There is no notified body capable to certify you for anything else than ISO 13485 for medical device companies. They can still review the Quality System that you built but sure they will find many reasons to say that it is not compliant. So in reality, if you want to sell a Medical Device in Europe, ISO 13485 is your only choice. 

How long it takes to create an ISO 13485 QMS?

If you hire or contract someone who brings templates of all of the necessary documents and then go about revising these templates to fit your organization. (4–6 months). It’s going to be a lot longer if you start with a blank screen. Document packages are available to purchase online. Choose a registered body (TUV, BSI, NSAI, etc) and schedule a Phase 1 audit. A Phase 1 only requires that you have the Quality Manual and SOP’s in place that comply with ISO 13485. (2–3 months)

Why is ISO 13485 important?

In the medical devices industry, quality management goes hand-in-hand with safety, and both are non-negotiables. Requirements like those set out by ISO 13485 are strictly enforced throughout every stage of a medical device’s life-cycle, including stages after manufacturing like delivery, service, and maintenance.

What are ISO 13485 requirements?

ISO 13485:2016 specifies requirements for a Quality Management System to produce ISO medical devices and related services that consistently meet customer and applicable regulatory requirements. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type, except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services supplied by the organization.

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