MEDCERT GmbH

Booth number 10E43

www.medcert.de

MEDCERT is one of the largest German Notified Bodies. Since 1994 we have been specializing in auditing, certification and conformity assessment of QM-systems and medical devices.

About us

MEDCERT is one of the largest German Notified Bodies. Since 1994 we have been specializing in auditing, certification and conformity assessment of quality management systems and medical devices.

Our locations on three continents, in Europe, North America and Asia, allow our customers access to local competence paired with the synergy of our global network.

Due to a high level of in-house expertise and competence, we are able to certify even highly innovative and complex devices as well as drug-device combinations.

Our Notified Body identification number is 0482.

Address
MEDCERT GmbH
Pilatuspool 2
20355 Hamburg
Germany

Phone: +49 40 22633250
Internet: www.medcert.de

Representative
Rep.-Office of MEDCERT GmbH
Room B104, WanRong Building, Nanhai Rd., 1029# Shekou
518067 Nanshan District, Shenzhen
P. R. China

Phone: +86 755 86329133
Internet: www.medcert-cn.com

Products and services

  • Certification according to ISO 13485
  • Conformity Assessment according to the MDD 93/42/EEC
  • Conformity Assessment of medical devices containing
  • aterial of animal origin according to Commission Regulation (EU) No. 722/2012
  • Conformity Assessment according to AIMD 90/385/EEC
  • For Australia, Brasil, Canada, USA, Japan: certification according to MDSAP
  • For Taiwan: certification according to TCP
  • For Malaysia: as registered CAB – Conformity Assessment Body

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