Tag Archives: Design Controls

FDA Quality System Regulation and ISO 13485

A ray of sunshine has appeared for medical device developers seeking to market their devices in the US as well as other territories.

Often, manufacturers wrestle with ensuring that their development process, activities and documentation aligns with both ISO 13485 and the Quality System Regulation (21 CFR 820).

US FDA has announced plans to harmonise the requirements contained in 21 CFR 820 with the content of ISO 13485:2016.  There is planned to be a fundamental revision to part 820, that will “supplant the existing requirements” with the content of the revised 13485 standard.  The agency intends the changes to reduce the compliance and record keeping burdens on manufacturers.

For the canny development organisation, little will actually change, as they will have planned their activities to achieve compliance with both the US and other territories requirements at the same time.  FDAs intentions will make their lives a little easier, removing the need for  translations between, for example document names, from the standard and part 820 terminologies.

For people embarking upon development with an eye on the US market for the first time, there’s likely to be one less hurdle to surmount once FDA’s intentions bear fruit.

Ultimately, the plans are good news for manufacturers who develop and market products for the EU, Japan, Canada, Australia (and the US), as all have regulatory requirements aligned with a single Quality Management Standard – leading to a reduction in compliance requirements for manufacturer Quality Management systems.

You may be thinking about seeking reassurance that your medical device development plans adequately address the regulatory requirements of the US and ISO 13485:2016 aligned regulations.  Get in touch with our team today.

 

Three ways to smooth your path for device development

Medical Device Development routemap v5.0 narrow viewSpring of 2013 still seems recent, so I was surprised to realise that the route map for medical device development will shortly be 3 years old. If it were a child in the UK, we would be able to get 15 hours free childcare a week from this September.

Children learn and grow at an alarming rate, especially when you’re looking back over what seems like a very short time and realise that the baby you remember holding in your arms “yesterday” is now a teenager.

The route map too is growing up fast. It’s being used across the world, from Australia, through Asia to Europe and on to North America. Users have fed back great experiences. Uses ranging from a desktop aide mémoire, a teaching aid, through to a planning and design review tool!

There comes a time when a child learns new skills, and naturally integrates them into their daily lives and toolkit.

We’re proud to announce the launch of the route map for medical device development 5.0 today. Numerous user suggestions have been incorporated in this new version, along with two new tracks; Intellectual Property and Market Research.

The route map continues to help you in three ways, it;

  1. Describes the journey you’ll embark upon, from a device idea through to launch.
  2. Sets out the main activities for each of 9 disciplines, through four stages of product development.
  3. Identifies the points where there are major interactions between disciplines.

And here it is…

Click to open a pdf version you can download

Click to open a pdf version you can download

You may already see how this picture will be helpful, whether you’re working in medical devices, combination products, pharmaceuticals, aerospace, defence, electronics…..

Send me your thoughts on how you can use the route map, because having a straightforward, independent view is always valuable.

Is herding cats easier than Design Controls?

With increasing pressures on healthcare businesses to get to market quicker and pressure to lower development costs, managing your design controls activities effectively has never been more important. However, regulatory expectations for medical technology development are continuously evolving. IMG_20150917_121626071There’s a natural tension between these two aims that is further complicated by the interactions and interdependencies of the major strands of product development. Following a process that is focused on doing the right things, at the right times, ensures the balance is maintained, shortens your time to market and reduces development costs.

This may all sound difficult to balance, managing to cope with these strands going off in sometimes wildly different directions.  If you’ve ever even thought about herding cats, you’ll appreciate the challenges involved.  However, in the latest of our programme of professional development training courses, in collaboration with Medilink West Midlands, we had the pleasure of focusing on how to manage control these strands,.Getting to grips with Design Controls

“Excellent, interactive aspect of the course was a brilliant idea”

 

 

Our goal was to provide attendees with an understanding of the crucial steps that need to be taken to ensure successful project completion. We outlined common pitfalls and how to avoid them as well as providing strategies to apply to existing and new projects.
Typical of the training events we deliver, the day was intensive and action packed, no time for delegates to switch off!

“Excellent, very well paced, good practical sessions”

Talking issues through
As usual, there were several full immersion workshops, interspersed with “classroom” sessions, as you can see from these photos. Delegates experienced first hand the key stages of defining and managing a project though to completion.

Delegates left the event full of enthusiasm and keen to implement what they’d learned.

“I wish we’d looked at this course 18 months ago”

They left better equipped for their next (or current) device project and perhaps more capable at herding cats too.

All of our professional development sessions can be run in-house and tailored to fit your specific needs. Some of our recent sessions include project management, medical device development, design controls, Human Factors and risk management.

Two little words… many interpretations

Risk Management…

… Two words that can elicit impassioned debate and sharp disagreement within an organisation, even with ISO 14971 in place to help!

We’ve been working closely over the past year with some of the world’s largest players in healthcare (and some of the smallest too) on just this subject.  Unsurprisingly, each organisation nneds a different flavoured way to identify, evaluate and control risks during development.  Now comes an opportunity to both share our (anonymised) experiences and learn from others in the field, as I (Matthew) get together with industry peers, AAMI and FDA later on this month at a Risk Management Summit in Washington DC.

The goals of the summit include:

  • Build a shared perspective on risk management among the diverse stakeholders who have roles in its application in healthcare technology
  • Identify barriers that are holding us back from that shared perspective and generate ideas for removing the obstacles.
  • Develop a shared plan for growing the discipline and practice of risk management in healthcare technology.

I’m looking forward to the summit and the opportunity to visit with friends who’ve moved to the DC area since my last trip.  If previous experience is any measure, this summit should be lively and deeply informative.

If you’re attending too, let me know, perhaps we can meet up over coffee or lunch.

 

We produced a summary report from our last summit meeting, let us know (hello(Replace this parenthesis with the @ sign)threecircles.eu) if you’d find a summary of the Risk Management Summit of use.