Coming Soon | KELLY THOMAS
This 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share lessons learned so your organization can benefit from the mistakes of others. We will review the latest changes to the regulations effective and in force and will draw out key developments and key dates. The looming EU MDR crisis: Protect your patients.
Regulatory affairs executives are currently focused on organizing and managing the final steps of the transition to align corporate strategies with new requirements and processes. This seminar will focus on the time remaining in the transition period and what companies can expect from notified bodies and regulators as the implementation deadline draws to a close, as well as clarifying areas of uncertainty such as implementing acts and defining sufficient clinical evidence.
The new EU Medical Devices Regulations (the MDR and IVDR) for medical devices and 2022 (for in vitro diagnostic medical devices). The European Commission and medical device coordination group (MDCG) are busy preparing the guidance documents and implementing legislation to ensure the Regulations can function. Notified bodies are also going through the designation procedure to ensure they can accept applications under the MDR and that products can be placed on the market under the new Regulations. However, there is still much to do, and progress has been slow.
|SEMINAR OBJECTIVES||WHO SHOULD ATTEND|
|1. Understand the regulatory requirements EU-MDR and the impact on Post Market Surveillance|
2. Understand how to apply those requirements
3. Explain the new regulatory expectations regarding Risk Management
4. Understand the consequences of non-compliance
|Those who work for manufacturers that market and commercialize devices in Europe including:|
- Medical Device Manufacturers and Professionals within Senior Management
- Regulatory Affairs Managers and Quality Managers
- R&D specialists, Development
- Manufacturing and Marketing Managers
- Internal and External Auditors, Importers
- Distributors and other medical device professionals in areas of Design
- Risk Management, and Post-market activities
DAY 1 (9 AM to 12 PM)
DAY 2 (9 AM to 12 PM)
COURSE DIRECTOR: KELLY THOMAS
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.