Course description
Essentials of In-Vitro Diagnostics Regulatory Affairs
This course will provide a basic awareness of the regulatory environment and an appreciation of some of the main regulatory processes and issues including:
- What are regulations and other controlling documents, and how can they be applied to IVDs
- What are the key regulated markets and regulatory bodies for IVDs
- Key elements of product performance (General principles of Safety and Performance)
- What is Risk management
- Labelling requirements
- Product files and their maintenance
- Submissions and certificates
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Suitability - Who should attend?
Suitable for
This course is designed for those:
- Regulatory affairs professionals who require an overview of in-vitro diagnostic devices
- Who work in functions allied to in-vitro diagnostic regulatory affairs (such as marketing, medical, quality, packaging and legal)
- From related professions (law, marketing and sales, healthcare, administration, project management)
- Those who work in regulatory authorities and those in the regulatory sector
Outcome / Qualification etc.
Benefits to participants
- This course will give you the knowledge tounderstand and communicate the basics of Regulatory Affairs for IVDs with colleagues
- Be taught by experts with extensive practical examples
- Build a network to support the rest of your career
Training Course Content
- Introductions
- Module 1: What is a Device?
- Module 2: Who is who
- Module 3: Legislation
- Module 4: Classification of devices
- Module 5: Conformity Assessment
- Module 6: Device Labelling
- Module 7: Clinical considerations
- Module 8: Post Marketing
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