Manufacturing Process Validation for Medical Devices: Introduction to Concepts and Methods

This one-day intensive course enables greater understanding of the key requirements for manufacturing process validation for medical devices, in line with the European Medical Device Regulations (MDR) and ISO 13485:2016 requirements in Europe. The aim of the course is to enable manufacturers to know what process validation evidence is necessary to demonstrate the manufacturing process is validated.

BSI’s ‘Manufacturing Process Validation for Medical Devices: Introduction to Concepts and Methods’ one-day training course has been designed to give manufacturers an awareness of EU regulatory and quality requirements regarding manufacturing process validation and the nature of ‘special processes’.

Practical activities throughout the day provide the opportunity to apply your knowledge. Learn the generally accepted principles of manufacturing process validation, understand installation, operational and process qualification so you can apply them to your organization.

How will I benefit?

This course will help you to:

  • Understand manufacturing process validation
  • Improve your understanding of the regulatory and quality standards requirements relating to manufacturing process validation
  • Be able to apply your knowledge to your organization, to enable it to produce compliant devices
  • Ensure auditable technical documentation meets applicable EU regulatory requirements