It’s one of the biggest annual events in the medical sector, so it’s no secret that visiting Medica can be a bit overwhelming. With 19 halls, nearly 4,800 exhibitors at the latest count and innumerable seminars, forums and conference sessions, it really pays, not just to pack your walking boots and a compass, but to plan your visit with care. That means prioritising, and I’d like to argue that for medical device manufacturers one of the biggest priorities right now is functional safety.
Medical device manufacture is a sector where even a single functional failure in a device can both cause serious harm or worse and produce enormous potential legal liabilities for the manufacturer. Clearly, it’s vital for manufacturers to minimise risk to acceptable levels.
However many companies find themselves facing considerable challenges in identifying and mitigating safety risks and ensuring that each device complies with a host of safety requirements laid out in standards including IEC 60601, ISO 14971, IEC 62366 and IEC 62304. That challenge is set to get harder as planned regulatory changes for the medical device sector from Europe and international standardisation bodies come into force in the near future, creating further time consuming and complex obligations for more and more companies. Yet non-specialist in-house risk and quality personnel aren’t always best placed to make this happen.
Lorit Consultancy sees Medica 2015 as the perfect opportunity to explain these issues to manufacturers and to demonstrate how working with the right functional security consultancy can overcome them. You can find us on stand 16G10-1 at Medica from 16-19 November 2015.
We’re a rapidly growing boutique consultancy based in Scotland, with extensive experience of working in Germany, the UK and elsewhere in Europe. One of the things I’m especially keen to talk about to device manufacturers is how they can learn from functional safety best practice in other sectors where the concept is better established. As a TÜV Rheinland FS Engineer (Automotive 6223/13), with experience of working on aviation transponders and electric motorbikes as well as medical devices, and years of development experience in both hardware and software, I’d like to think I’m in a good place to do that.