Course description
Design, Development and Certification of Medical Devices
This Masterclass is also module 14 of the MSc Regulatory Affairs and will help you to gain an understanding of the design, manufacturing and quality management requirements for product development, the importance and concepts of risk management and the ways in which risk is managed from the design stage onwards, so that you can provide appropriate advice on the key regulatory issues affecting design, certification and manufacturing of medical devices.
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Suitability - Who should attend?
Suitable for
- Students of the TOPRA MSc programme
- participants from the medical device industry who wish to develop their knowledge of the design development and certification of medical devices
- participants from allied industries who wish to have a comprehensive understanding of the subject
Outcome / Qualification etc.
Benefits for participants
This course will enable you to:
- Be able to critically evaluate the design of a device including the materials it is made of
- Demonstrate a critical understanding of the safety and performance of devices using applicable product standards for the EU and other global markets
- Critically evaluate the principles and practice of risk management as set out in ISO 14971 to a level where it can be applied to a complex medical device
- Be able to create and appraise the documents required to apply for certification of medical devices for the EU and other global markets
- Give appropriate advice to the medical device team on key regulatory issues affecting the design, development and manufacturing of devices
- Produce the necessary technical documentation within project timeframes
- Critically appraise and evaluate communications from competent authorities, notified bodies and research publications covering the design, development and certification of medical devices globally
Training Course Content
This Masterclass will cover:
- Design / development planning, functionality and prototyping
- Risk Assessment
- Statistical approaches to design
- Material choices and biological safety assessment
- The importance of ISO standards in device development
- Testing and validation
- Inputs and outputs
- Rapid prototyping
- Assessing usability and performance
- The role of statistics in the design development tool kit
- Certification: Developing documentation to support regulatory assessment of a new device
- Specialised processes, including sterilisation
- Packaging design
- Software as a medical device
- Post-marketing design and development activities
- Global standards, regulatory requirements and the links with the technical documentation page.
Expenses
The full tuition price for students is 1500 GBP . The price for participants is 1700 GBP
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