Something may have escaped your notice in the talk about the revised version of ISO 13485, published in 2016 (ISO 13485:2016 is the International Standard for Medical devices — Quality management systems — Requirements for regulatory purposes).

ISO 13485 is a harmonised standard, which means you can use compliance with ISO 13485:2016 as evidence of conformity with the requirements of several EU Directives:

  • Medical Device Directive (MDD),
  • In-vitro Diagnostics Directive (IVD),
  • Active Implantable Medical Device Directive (AIMDD).

There is a transition period, after which certification won’t be possible to earlier versions of the standard.  To complicate matters, the transition period ends on different dates, depending upon your current certification.

Marketing medical devices in Canada?

You had until 1 January 2019 – so time has definitely run out!

Current certification to ISO 13485:2003?

you had until 28 Feb 2019 – so time has definitely run out!

No certification to ISO 13485:2003?

you have until 1 April 2019 – so time has definitely run out!

In either case, the transition end dates may sound like a long time away yet.  Time flies, and if you’re considering certification to ISO 13485:2016, you have several steps to take, not least of which is to understand what you really must be doing to be ready for certification.  Don’t underestimate the time and effort required to get there.

Help is at hand!

No need to worry about how you’ll get ready in time.  We have helped clients make the transition to ISO 13485:2016 from either an informal Quality Management System, or holding an ISO 9001 certification.  Our experience and knowledge has been assembled into our 13485 Health-check turn key service, to give you a clear picture of how your organisation stacks up against the requirements of the standard. Benefits our clients say they’ve achieved include

A pain free assessment of what you need to do, so you can take the right actions.

Guidance and help for changes you make so you’re not shooting in the dark.

Frees you up to play to your strengths, instead of trying to get to grips with something outside your comfort zone.

What you get when we schedule your 13485 Health-check™:

  1. An on-site gap analysis of your current quality management processes and procedures against the requirements of ISO 13485:2016,
  2. Pre-planned for a date and time that is convenient to you,
  3. Recommendations for improvements or changes to address oversights or weaknesses,
  4. Recommendations for procedures and processes that may be required,
  5. Identification of changes that may be required to your existing procedures and processes,
  6. A comprehensive report detailing the origins of all our recommendations and how they relate to ISO 13485:2016 clauses,
  7. Time with us to create your action plan to address the recommendations.

All this for a single, fixed, fee.

Whether you hold certification to ISO 13485:2003, ISO 9001 or not, we can help ease your transition activities.

Get in touch now, before that clock gets any closer to zero.