Are you involved in the development, manufacture or supply of custom-made medical devices? CMS SciDoc, the regulatory joint venture between Compliance Management Solutions and SciDoc Solutions, is running a one-day training session on the key regulatory requirements for custom-made devices in Australia and Europe, with practical guidance to help you understand your obligations and prepare the required documentation.
Australia: TGA requirements
- Definition and regulatory framework for custom-made devices
- TGA requirements and applicable pathways
- Manufacturer and sponsor responsibilities
- Documentation and compliance requirements
- Supply and post-market obligations
Europe: EU MDR 2017/745
- Definition of custom-made devices under the EU MDR
- Regulatory requirements and applicable exemptions
- Manufacturer responsibilities
- Technical documentation and statement requirements
- Clinical evaluation and post-market surveillance
- Requirements for placing custom-made devices on the EU market
Why attend
- Understand the regulatory requirements in Australia and Europe
- Identify the documentation required for compliance
- Understand manufacturer and sponsor responsibilities
- Gain practical insight into managing custom-made devices
One day, practical and focused, covering Australia and Europe.
To express your interest, or to discuss a bespoke session for your team, please contact our regulatory team.