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Technical documentation in medical technology

What content is taught in the seminar?

  • The four levels of statutory and normative regulation at international, EU and national level
  • An insight into the evolution of standards and the background to harmonized standards
  • The documentation of the medical device cycle in different jurisdictions (USA, EU, STED) and their documentation structures (MDR, ISO 13486, FDA, GHTF)
  • The most important annexes of the MDR (I, II, III, XV, XIV) with a focus on the rights and obligations of the persons involved after placing on the market
  • An excursus on the scope of the MDR, its assessment procedures and products without an intended medical purpose
  • The rules for sampling and the topics to be audited

What are the learning objectives / benefits of the seminar?

  • You will acquire knowledge of the regulatory requirements and the key elements and content of technical documentation.
  • You will know how to set up and update your technical documentation systematically and in line with requirements.
  • You will benefit from practical examples and will be able to optimize the certification process using your newly acquired knowledge.  
  • The transfer of knowledge into your own practice is made easier and the time and effort required for planning and implementing product certification is reduced.

Which target group should the seminar address?

The seminar is aimed at the group of people involved in the creation of technical documentation. This includes:

 

  • Management
  • Employees of the quality management department
  • Employees of the Approvals/Regulatory Affairs department
  • Employees from Research and Development

What requirements must the participant fulfill?

No special knowledge is required.

Course times:

  • 08:00 - 17:00 


Further information and costs:

  • A handout and the training documents used will be provided as accompanying material. Each participant will receive a certificate of attendance after completing the seminar. Up to 8 people can take part in a seminar.
  • 750,- Euro plus tax


Training location:

The seminar will take place at the Ginsheim-Gustavsburg site:

Bertrandt Medical GmbH
Im Weiherfeld 1
65462 Ginsheim-Gustavsburg

Your Contact

Elisabeth Medele

Bertrandt Academy

Phone: +49 7034 656-10104
Contact