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 relevant reports and listings in a timely and correct manner. The product data from the development and manufacturing phase must be compiled into a submission file that meets formal and content requirements. Special topics such as classification, safety & efficiency and, above all, substantial equivalence must be described extensively in documentation.
In the two-day seminar, the requirements for the technical and organizational documentation to be produced will be worked through and compared with the EU. The focus is on the practical realization of the task. The participants therefore receive lots of practical tips and resources.
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 inspections, approach of the inspectors, consequences (e.g. warning letters)
- Content and formal requirements for the 510(k) file to be generated
- Substantial Equivalence
- Human factors, usability or suitability for use
- 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, Initial Marketing Officers, Development Managers, Regulatory Affairs Employees and Employees Responsible for U.S. Regulatory Compliance.
Prior knowledge
Not required.
Notice
Participation in the seminar “Fundamentals of Regulatory Affairs International” is recommended in advance.
Funding opportunity
ESF funding is possible. Further information
KONTAKT:
TuttlingenTuttlingen & Online
