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DNV MEDCERT certification services

DNV MEDCERT Certification and Notified Body for Medical Devices

DNV MEDCERT GmbH is one of the largest German Certification and Notified Bodies and is based in Hamburg, Germany. The identification number as a Notified Body is 0482.

Since 1994 MEDCERT has specialized in auditing, certification and conformity assessment of quality management systems and medical devices. MEDCERT became part of DNV in January 2022 (read the press release here).

Our services

DNV MEDCERT audits and certifies quality management systems and medical devices for conformity with EN ISO 13485 and compliance with European regulatory requirements for medical devices as well as national laws. It exclusively certifies medical devices and healthcare products.

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.

DNV MEDCERT services include:

  • Notified Body assessment according to Regulation (EU) 2017/745 - the European Medical Device Regulation
  • Certification according to ISO 13485
  • Certification according to MDSAP (Medical Device Single Audit Program) for Australia, Brasil, Canada, USA, Japan
  • Audits under TCP (Technical Cooperation Programme) for Taiwan
  • Certification services offered as a registered Conformity Assessment Body for Malaysia, including MS ISO 13485, GDPMD (Good Distribution Practice for Medical Devices) as well as Technical File Review

The Quality Policy of DNV MEDCERT is available here.

If you need assistance for your certification process, we have prepared the lists of companies specialized in establishing and implementing of company-specific quality management systems and technical documentation by country/region. To see the lists please go here.

Contact medcert-info@dnv.com for more information.

 

Questionnaire for Quotation

A form to apply for a quote for certification services according to MDR, ISO 13485, MDSAP and TCP (Taiwan)

 

Application for Certification

A form to apply for certification services according to MDR, ISO 13485, MDSAP and TCP (Taiwan)

 

Price List

 

Verification of Complaints

 

Procedure for the Certification and Conformity Assessment of MD and QMS

 

General Order and Payment Conditions

Important MDR Documents

Important MDR Documents