What is the webinar about?

The European Commission have recently released MDCG guidance (MDCG 2024-10) to help support the clinical evaluation of orphan devices. This guidance provides helpful information to address the difficulties on the practicality of obtaining clinical evidence for these devices. This webinar will provide BSI’s interpretation of the guidance and provide manufacturers with some practical help on how to apply for a conformity assessment of an orphan device. 

What will participants gain?

Participants will gain a better understanding of the MDCG guidance and will be aware of the process to apply to BSI with a device that qualifies to the criteria. 

Who should attend?

Medical Manufacturers who may have devices that meet the definition per guidance MDCG 2024-10. 

Speakers

 
Richard
Holborow
Head of Clinical Compliance

Email: us.medicaldevicesbsigroup.com

Phone:  +1 888 429 6178

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