content
By far the most common type of product approval for medical devices in the USA is the 510(k) submission. But here too there are different types of approval. The question of the structure and content of the documentation to be submitted arises again and again. In addition to the necessary theoretical background for the desired approval, it is necessary to carry out the corresponding reports and listings in good time and correctly. The product data from the development and manufacturing phase must be compiled into a submission file that meets the requirements in terms of form and content. Special topics such as classification, safety & efficacy and, above all, substantial equivalence must be described in detail in documentation. In the two-day seminar, the requirements for the technical and organizational documentation to be generated are worked through and compared with the EU. The focus is on the practical realization of the task. The participants therefore receive many practical tips and sources.
topic overview
- Who is the FDA and how is it organized?
- Types of submissions: PMA, HDE, IDE, 510(k)
- Listings, Registrations, GUDID and Classification
- Types and contents of the inspections, procedures of the inspectors, consequences eg warning letters
- Content and formal requirements for the 510(k) file to be created
- substantial equivalence
- Human Factors, Usability or Serviceability
- Risk management, foreseeable misuse and vigilance in the development process
- Labeling, biocompatibility, process validation, computer systems (Part 11) and MD vigilance
target group
Managing directors and those responsible for initial marketing, development managers, regulatory affairs employees and employees who are responsible for compliance with legal regulations in the USA.
previous knowledge
Not mandatory.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
