Description

NEW (TODO: complete description):

  • Certification of medical products, MDD, CE, FDA 
  • Certification of quality management systems, ISO9001, ISO13485 etc.

 

OLD

This course introduces into the most relevant norms, laws and regulations in

  • IT: e-commerce, data security, privacy
  • Health care: FDA, reimbursement ("Sozialgesetzbuch"), medical device directive

The laws are discussed with scope national, EU-wide and US

Targets

Upon completion of this course the student should be able to

  • List all relevant norms and laws in the EU and US
  • Explain the impact on the realization of projects (product registration,  clinical trails, online data, ...)

 

 

 

 

Scratch

  • Wie erstelle ich ein QM Handbuch?
  • Übergeordnetes QMS