KEMA has this month opened a new office in Munich, which is to focus specifically on the provision of certification services to medical device manufacturers. As part of the program of activities linked to the opening of the new office, KEMA is organizing a seminar on May 12, devoted to topical regulation issues relevant to producers of active and non-active medical devices.

Southern Germany is Europe’s ‘Health Valley’ – the continent’s leading area for innovation and production of medical devices. ‘Because we’re on the clients’ doorstep, we can provide a quick, responsive service,’ explains Regional Manager Franziska Baumgarten. ‘Rapid turnaround times are increasingly important when it comes to bringing new products to market. Certainly in the medical sector. Having an office here enables us to give our existing clients better support.’ 

Health-related matters
Around the world, ever-greater emphasis is being placed on health-related matters. Public health campaigns are commonplace and the authorities are consistently working to encourage people to adopt healthier lifestyles. Such activities also have the effect of stimulating innovation and development in the market for medical devices. And, where such devices are concerned, quality is literally a matter of life and death. ‘Consequently, the certification of medical devices is compulsory,’ points out Baumgarten. ‘Furthermore, this market – like many others – is increasingly global, and international harmonization is being sought in many areas. We are contributing actively to developments in this field.’

Fully-fledged
Establishing a presence in southern Germany is part of KEMA’s strategy of growing its medical device certification business. Not only in Europe, but also in the USA and the Far East. The new Munich office will initially be fairly small, but will develop into a fully-fledged operational entity over time.