TÜV NORD CERT GmbH of Essen at MEDICA 2021 in Düsseldorf -- MEDICA - World Forum for Medicine
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TÜV NORD CERT GmbH

Am TÜV 1, 45307 Essen
Germany

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Hall map

MEDICA 2021 hall map (Hall 10): stand H56

Fairground map

MEDICA 2021 fairground map: Hall 10

Contact

Ralf Thomsen

Medical Device International

Phone
+49 (0)160/8880333

Email
rthomsen@tuev-nord.de

Tanja Frankewitz

Medical Device International

Phone
+49 (0)160 8882730

Email
tfrankewitz@tuev-nord.de

Project Management

Medical Device International

Phone
+49 (0)201/825-2236

Email
medical@tuev-nord.de

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Our range of products

Product categories

  • 07  Medical services and publications
  • 07.16  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

Our products

Product category: Certification and testing of medical devices, quality assurance

Medical technology

  • Surveillance according to European Directive MDD (93/42/EEC) and taking MDR (2017/745) §120 into account
  • Certification of QM systems according to EN ISO 9001 and EN ISO 13485 and preparation of medical devices (up to critical category B) to EN ISO 13485 / KRINKO
  • Medical Devices Single Audit Program (MDSAP)
  • Certification of medical supply stores to EN ISO 13485:2016
  • Electromagnetic compatibility for medical devices
  • Combined security and safety risk assessment for medical devices

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Product category: Certification and testing of medical devices, quality assurance

Biotechnological safety

  • Testing of microbiological safety cabinets
  • Testing of cystostatic isolators

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Product category: Certification and testing of medical devices, quality assurance

Healthcare

  • Certification of occupational health and safety management to DIN SPEC 91020
  • Certification of clinics, hospitals, health centres and other organisations in the social and medical care sector according to DIN EN 15224 and DIN EN ISO 9001
  • Certification of rehabilitation clinics based on SystemQM
  • ISMS assessment – information security management system gap analysis
  • Certification of personal information management systems to BS 10012

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About us

Company portrait

TÜV NORD CERT GmbH

Technology plays an ever more important role in medical diagnosis and treatment. This also means that the legal framework for manufacturers and sellers of medical devices is subject to continual change.  

With our internationally recognised testing and certification programme we offer hospitals, clinics, medical practices, rehabilitation centres and medical device stores maximum assurance of safe operation of medical devices and appliances.

Our services include testing and certification for CE marking, MDSAP (medical device single audit programme) and QM systems to ISO 13485. We also offer certification for active and non-active medical devices and active implantable devices.

Nofication and accreditation
  • Notified Body (CE 0044) for medical devices
  • Accredited certification body for DIN EN ISO 13485
  • Approval as notified body for the new medical device regulation (EU) 2017/745 is expected shortly (4th quarter of 2021)
TÜV NORD CERT – Your notified partner and certification body for certification and testing of medical devices, quality management and assurance, and so much more.