You’ll probably recall me mentioning ISO 13485, and its relevance to ensuring that you don’t fail?

If you’ve reached the conclusion that it would be advantageous to show customers, regulators or investors that you’re working in an appropriate way, then you’ll see the benefit of having a certificate of compliance with ISO 13485.

Potential investors have asked for evidence of certification, even before they get to considering due diligence – so this really helps get funding

Whether you’re thinking of a medical device, an in-vitro diagnostic device (IVD) or an active implantable medical device, you can use compliance with ISO 13485:2016 as evidence of conformity with the requirements of the relevant EU Directives.

Within all the noise about changes to ISO 13485, you may have missed any mention of timings.  There was a transition period, after which certification won’t be possible to earlier versions of the standard.  It used to be complicated by a range of transition end dates, depending upon your current status of certification – but that’s become a lot simpler this year:

If you already held current certification to ISO 13485:2003
you had until 28 Feb 2019 to transition to the 2016 version – so time has definitely run out!

Maybe you hadn’t started to work on certification to ISO 13485?
you had until 1 April 2019 to get certified to the 2003 version of the standard – so time has definitely run out – you have no option but to get certified to the 2016 version.

In either case, the transition end dates have now passed, so falling back on the older version of the standard is not viable.

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.

How can I get started?

It can be a worry, stepping into the unknown.

To help ease those worries, to reduce the risk and uncertainty, there are some key things that you’ll need to consider (or ask someone else to consider on your behalf – with a “fresh pair of eyes”):

  • Which parts of the standard are relevant (it’s unlikely that all parts are relevant for you)
  • Make a frank appraisal of how well what you do, what you write down, matches up with what your business, and the standard, need
  • Note what isn’t quite up to scratch, what is already working well
  • Plan how to address the things that need fixing or putting in place

As it happens, we’ve 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 we could take the right actions.

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

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

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

There’s no time like the present to get started – so get in touch right now!