Primara Test- und Zertifizier-GmbH

Endorse Company
Company Profile Our services As a laboratory for medical devices, we support you in placing your product on the market. The safety and reliability of your product is essential in order to be successful. Our aim is the sustainable development of safety and quality our your products as well as the uncomplicated and fast processing of market authorization. Primara is a recognized testing laboratory for medical devices according to Directive 93/42/EEC and 90/385/EEC and DIN EN ISO/IEC 17025. We offer tests for medical devices for example for the following standards: IEC/EN 60601-1 2nd und 3rd edition IEC/EN 60601-1-6 Usability IEC/EN 60601-1-8 Alarm systems IEC/EN 60601-1-11 Medical care in home environment IEC/EN 60601-2-2 High-frequency surgical equipment IEC/EN 60601‑2-4 Defibrillators IEC/EN 60601-2-10 Nerve and muscle stimulators IEC/EN 60601-2-25 E lectrocardiographs IEC/EN 60601-2-26 Electroencephalographs IEC/EN 60601-2-40 Evoked response equipment Capture new markets with our support! Through our OHSAS and SCC accredited partner QPS we can offer you a fast NRTL certification for Canada and USA.