Service

MEDCERT GmbH

Pilatuspool 2 , 20355 Hamburg
Germany

Telephone +49 40 2263325-0
Fax +49 40 2263325-15
info@medcert.de

Trade fair hall

  • Hall 5 / D02
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 5): stand D02

Fairground map

MEDICA 2016 fairground map: Hall 5

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies

Technical equipment management, Test houses / Certification Bodies

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.02  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

Our products

Product category: Technical equipment management, Test houses / Certification Bodies, Certification and testing of medical devices, quality assurance

What is ISO 13485

Standard ISO 13485 is an industry-specific alternative to ISO 9001 and is also based on the overall picture of business processes. ISO 13485 also in conjuction with Directive 93/42/EEC European Rat specify die requirements for a Qualitymanagement-System (QMS) for a medical devices manufacturer. The focus of the standard is on the product’s safety.
For the manufacturer, who have already gained a certification according to ISO 9001, lends itself to the certification according to ISO 13485, since the both standards extensive consistent based requirements.

Standard is divided in five main parts:

- Qualitymanagement – System
- Management requirements
- Resource requirements
- Product realization
- Measurement, analyse and improvement

If you are interested in a quotation, please send us back the completed questionnaire.

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About us

Company details

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.

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Company data

Number of employees

20-49

Foundation

1993

Area of business

Medical Services and Publications