MEDCERT (CE 0482) is one of the biggest and most experienced German Notified Bodies.
We are focused exclusively on medical devices and the medical device industry. As experts in certification and the testing of medical devices we operate in almost 30 countries around the world and have been active in international markets for over 20 years. We established all our procedures to provide fast and more effective certification process of high quality. Due to our centralized organizational structure, we are flexible and have a short decision-making process.
MEDCERT offers you a wide range of certification services in the field of quality management system, like certification according to ISO 13485, Directive 93/42/EEC, Directive 90/385/EEC. We certify various, innovative and highly complex medical devices up to combination products. Our identification number is CE 0482.
Beside the certification according to the European standards, MEDCERT offers you-partly in cooperation with a highly qualified partners-international certification services, like: TCP for Taiwan, PAL for Japan, CMDCAS for Canada. MEDCERT is a CAB – Conformity Assessment Body for Malaysia.
MEDCERT can help you meet the requirements of the EU Directives for easier and faster access to the European Market as well as further markets.