INNOTERE GmbH

• DE/CA82, Landesdirektion Sachsen Referat Marktüberwachung
  GermanyContact the authority →

Devices placed in 32 countries

• Austria27
• Belgium27
• Czechia27
• Germany27
• Denmark27
• Spain27
• France27
• Greece27
• Croatia27
• Hungary27
• Ireland27
• Italy27
• Lithuania27
• Luxembourg27
• Malta27
• Norway27
• Poland27
• Portugal27
• Romania27
• Sweden27
• Slovenia27
• Bulgaria26
• Cyprus26
• Estonia26
• Finland26
• Iceland26
• Liechtenstein26
• Latvia26
• Netherlands26
• Slovakia26
• Türkiye26
• XI26

3 contacts identified

• HD
  HEINEMANN Dr. Sascha

  PRRC
  View profile →
• HEINEMANN Dr. Sascha
  - Confirmation of conformity and release of the products (placing on the market). - Ensure that post-market surveillance obligations are fulfilled including reporting obligations - MDR Articles 87-91. - Ensuring that the technical documentation (TDs) and the EU declarations of conformity are properly prepared and that they are properly updated/amended as necessary (MDR Art. 15 Para. 3 No. b) - Approval of the manufacturing documentation for each custom-made product
  Hidden
• TAUCHERT Rica
  - Verify the conformity of the products (articles, intermediate and final products) in an appropriate manner according to the company's own QMS, prior to release. - Collecting and evaluating reports of risks - Reporting and analysis of serious incidents and safety corrective actions and trends in the field (Articles 87, 88 and 89) - custom-made product: the appropriate documentation is available, the declaration is prepared in accordance with Annex XIII MDR
  Hidden

• — 2 certificates — INNOTERE
• — INNOTERE