Course description
The Medical Device Introductory Course
With a growing trend in the crossover between pharmaceutical and medical device regulatory affairs, it is becoming increasingly important for pharmaceutical regulatory professionals to be aware of the issues surrounding medical device regulatory affairs.
Put together by practising medical device regulatory affairs professionals, this newly researched and updated course is demanded by regulatory affairs managers who wish to get their people up to speed on current European medical device regulatory practices.
After three days you will return to your office a more confident and proactive medical device regulatory affairs professional who will be able to determine which directives apply to which products, classify medical devices, assess borderlines issues and establish and maintain an internal audit programme and a supplier audit programme.
The course will also enable you to prepare and manage a third party audit, recognise diverse country requirements, advise on how to conduct a clinical investigation and implement a copy approval process.
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Suitability - Who should attend?
Suitable for
- Those with 1-2 years experience in Medical Devices
- Those who want a broader understanding of Medical Devices
- Anyone who works in other areas of Regulatory Affairs who is looking to move into, has an interest in or would like further understanding of Medical Devices
- Anyone in medicines regulation who works with Drug Device Combination Products
Outcome / Qualification etc.
Benefits to participants
participants will learn:
- The role of the essential requirements / harmonised standards and how to demonstrate conformity.
- The different conformity assessment routes and how to select the most appropriate route for their product
- The role of risk management in pre and post market phase and be able to advise on a risk management policy and procedure.
- The need for clinical evidence for CE marking
- The needs of payers and how to include these as part of the development of the device regulatory package.
- The key elements within a PMS system
- The criteria for vigilance and the Competent Authority (CA) expectations
- The minimum requirements and CA expectations for implementing an FSCA.
- The impact of marketing literature on regulatory status
- The unique requirements of the IVD Directive
Training Course Content
- Medical Device Classification & Drug DeviceBorderline
- Case Study (Part 1)
- Day 1 Re-Cap & Day 2 Intro
- Conformity Assessment & ISO 13485
- Clinical Evaluation & PMCF
- In-Vitro Diagnostics
- Case Study (Part 2)
- Day 2 Re-Cap & Day 3 Intro
- Post-Market Surveillance, Device Vigilance &
FSCA - Case Study
- Risk Management (Part one)
- Risk Management (Part two)
- Beyond CE Marking
Expenses
The full tuition price for students is 1500 GBP. The price for participants is 1700 GBP