• Richard: Unparalleled insider knowledge from renowned notified body BSI, sharing exclusive industry insights
• Amie: Seasoned regulatory professional and former notified body leader, with extensive manufacturer feedback and practical experience

Key topics OF DISCUSSION

• Notified body capacity: Current status and future outlook, with insights into the impact of regulation 2022-14 and collaborative efforts among notified bodies
• Overcoming challenges: Strategies for both legacy and new devices, ensuring successful market access and maintaining a robust product pipeline in Europe
• Streamlining the certification journey: Easy fixes manufacturers can implement to improve submissions, enhance the certification process, and simplify their path to compliance
• Certificates with conditions: Latest developments, common challenges, and guidance on effective approaches
• And more! Additional insights and topics to provide a comprehensive understanding of EU regulations, including answering your questions!
  
  

Benefits for Attendees

• Gain exclusive insights and industry knowledge from insiders
• Demystify EU regulations and alleviate fears
• Obtain practical guidance to navigate the European market successfully
• Learn actionable strategies to enhance submissions and streamline the certification process
• Stay updated on certifications and conditions
  
  

Richard Holborow – Head of Clinical Compliance, BSI

Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specializing in implantable cardiac devices and electrophysiology. Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organization. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.

Amie Smirthwaite – Sr. VP of Intelligence & Innovation, RQM+

Dr. Amie Smirthwaite is the Senior Vice President of Intelligence and Innovation at RQM+ and joined the company in March of 2020. A clinical and regulatory affairs expert, Amie has over 25 years of postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems, and clinical data evaluation.  

 
She is leading the RQM+ Intelligence and Innovation team, following her role as former Global Head of Clinical Compliance at BSI. Amie developed BSI’s clinical compliance team and lead clinical aspects of BSI’s successful MDR designation and has contributed to numerous clinical and regulatory guidance documents and training.