EU Device Regulations, Unannounced Visits and Key Compliance Requirements–NB Expectations

Join the RAPS San Francisco Bay Area chapter for a full day of regulatory sessions related to  the EU parliament’s latest decisions on the future of medical devices regulations in Europe,  the EU commission’s recommendation and guidelines on unannounced visits and key requirements critical to demonstrating compliance to both existing MDD and the impending Medical Devices regulations. Presentations will include:

MDD Revisions
Will discuss the draft regulations including highlights of recent amendments compromise and those under further consideration.

Unannounced Visits 
Will discuss what companies need to do differently to prepare and what to expect from Notified Bodies.

Technical Files and Design Dossiers
Will confirm current regulatory requirements and interpretations of key sections such as Essential Requirements, Risk Management, Supplier management, PMS and PMCF.

Understanding Clinical Equivalence
Will discuss how you can demonstrate clinical equivalence, which is critical in conducting clinical evaluations and determining whether new investigations are required versus drawing from pertinent data of comparable device(s).

Risk Management
Will discuss understanding ISO 14971:2012 and what manufacturers need to consider doing differently from a practical standpoint.

Speakers:

• Paul Brooks, senior vice president, healthcare solutions, BSI Healthcare
• Laurel Macomber, MS, PMP, RAC, product expert, BSI Healthcare
• Ronald Rakos, PhD, RAC, team leader, vascular devices, BSI Healthcare
• Ibim Tariah, PhD, technical director, BSI Healthcare