Introduction to Quality and Regulation for Medical Product Development, 5 cr

Core content

• Most common phases of R&D project. From research to the product launch.
• Quality Systems for medical device development. Why it's needed? And how we can use it to improve the product safety?
• Medical Devices. Definitions, packaging, sterilization, registrations and regulatory.
• Testing (mechanical, biomechanical, clinical, and statistical), standards and safety (electrical, biological).

Complementary knowledge

• Understanding the connections between different phases of the project, and to have overall knowledge about the whole process.
• Deeper understanding of QS
  (including SOP, CAPA, Auditing, DMR, traceability, risk assessment)
• Understanding the main equalities and differences of regulatory demands between the different countries.
• To understand the main methods and why/where we need these results?