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

Core content

• Product classification, life cycle and special features of the industry
• Regulatory framework and authorities
• Key regulations, standards, and guidelines
• Safety and risk management
• Preclinical and clinical evaluation and testing
• Ethics and sustainability
• Product report and presentation
• Peer reviewing
  

Complementary knowledge

• Understanding the connections between different phases of the product life cycle and product development process
  
• Understanding the main differences between EU and US regulation
  
• Deeper understanding of quality system including SOP, CAPA, auditing, DMR, traceability and risk assessment
  
• Deeper understanding why evaluation, testing, verification and validation are mandatory

Specialist knowledge

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