KEMA Quality B.V.

Utrechtseweg 310
6812 AR Arnhem
Postbus 5185
6802 ED Arnhem

Phone: +31 26 356 91 11
Fax: +31 26 3525800


Company Contacts
Department/ Name Address

dr. Anja Wiersma
Company Figures
Number of employees 1000-4999
Sales volume 100-199 Mio US $
Export content > 75%
Year of foundation 1927
Area of business Electronical Equipment / Medical Technology


Language: German Language: English Company Profile

KEMA – Your Notified Body for innovative medical devices
You manufacture medical devices. Your products must be furnished with certificates in order to be allowed on the market in various countries. Moreover, your Quality Management System also has to comply with the regulations. Obviously, you’re looking for a Notified Body that ties in perfectly with your needs and expectations.

We can offer you:

Short turnaround times
Good project planning
No hidden costs; rather, a clear cost structure
Know-how and experience
An independent, thorough certifier that is also a reliable and flexible partner
A Notified Body with an outstanding international reputation When you choose KEMA, you’re choosing more than just a certifier with an outstanding international reputation. You can call on KEMA virtually everywhere in the world. KEMA integrates CE certification with ISO 13485 audits and that saves you a substantial amount of audit time. Besides that, KEMA is flexible. Your permanent contact gears the certification process to your organization. KEMA auditors are specialists. They combine their knowledge with extensive experience in the medical industry. KEMA participates in all the MRAs and is officially recognized by the FDA and Health Canada. KEMA is a reliable, responsible partner. One that knows your interests are best served when your time to market is as short as possible. You save a lot of time and money with KEMA’s one-stop shopping.

Be smart, contact KEMA!