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           

KEMA has proved again and again over the years that it complies with all these points. We’re proud that we are one of the five largest Notified Bodies in the world. KEMA is one of the market leaders in this market! The quality, knowledge, and service of KEMA are the benchmark in the medical industry. 

One-stop Shopping: KEMA!
You can call on KEMA for both your product certification and the certification of your Quality Management System. This efficiency ensures that valuable time is saved. The European Union has designated KEMA as Notified Body for the following directives:

• 90/385/EEC Active Implantable Medical Devices
• 93/42/EEC Medical Devices 
• 98/79/EEC In Vitro Diagnostics
• 2000/70/EEC Blood Directive
• 2003/32/EEC Medical devices manufactured utilizing tissues of animal origin
• 89/336/EEC EMC Directive
• 99/5/EEC Radio and Telecommunications Terminal Equipment            

KEMA is a partner of the FDA for:

• 510(k)           

KEMA is accredited to certify the following quality systems:

• ISO 13485:2003
• ISO 13485 (CMDCAS accredited)
• QSIT inspections 
• ISO 9001:2001
• In addition, KEMA is accredited for ISO 14001, 18001, OSHA.            

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!
For Notified Body Recomendations click here.
Guidelines relating to medical devices Directives (MEDDEV documents).