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HES6408 Product Development for Therapeutics - Perspective for Medical Devices (3 days)

Aims and Objectives

This subject aims:

• To develop an understanding of the process by which medical devices are developed and made compliant with regulatory codes.
• Demonstrate the importance of product specification, design for manufacturing, and market expectation.
• Explain methods used for certification of devices.
• Provide an introduction to new design principles including nanotechnology and microtechnology.

On completion of this subject students will be able to:

• Create a process plan for the development of a medical device.
• Explain the principles eschewed in the international standards.
• Demonstrate an understanding of the international regulatory framework and the methods used to obtain certification in different jurisdictions.

Content

• Background - why the regulatory situation is as it is.
• Design for Manufacture (DFM).
• Introduction to manufacturing methods such as 3D CAD and Simulation, Rapid prototyping, prototype scale manufacturing, electronics, software and assembly and packaging.
• Importance of processes for defining specifications including considerations of disposability, reusability, sterilisation, cost of ownership and market needs.
• GLP and GMP for Medical Devices.
• Medical device or laboratory device?
• Diagnostic or Therapeutic?
• Regulatory regimes ( Australia , Europe, USA ,etc).
• Harmonized Euro Norms and ISO Standards.
• IEC 64641 Electrical Standard for Medical Devices.
• Methods for compliance certification.
• Problems, pitfalls and potholes - where are the regulatory gaps?
• New designs and technologies - nanotechnology, microtechnology, microengineering principles, Microfluidics, hand held devices and ambient intelligence.

Recommended Reading

To be advised at the beginning of the course, but will include:

• Standard IEC64641-1
• ISO 13485 - Medical Device Standards
• FDA 21 CFR 820 - GMPs for Medical Devices

Format

The course consists of a lively mix of presentations, group exercises, and discussions. At the end of the course, there will be a short quiz to test understanding. Copies of all presentation slides and handouts will be provided.

Out of Class Assignment

Participants are offered the opportunity to complete a GMP assignment following completion of the course. This will be facilitated and supported remotely by SeerPharma's team of consultants, and successful completion will be rewarded with additional certification.

There is no additional charge for this.