Episode description
This show was recorded 27 July 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. Thank you for listening!
Listen to a captivating and informative conversation aiming to help you master EU compliance, where BSI's Global Head Clinical Compliance Richard Holborow and RQM+'s Senior Vice President of Intelligence and Innovation Amie Smirthwaite come together and address current challenges and provide valuable insights on navigating the complex landscape of EU regulations.
This conversation will:
- Empower manufacturers
- Alleviate fears
- Equip manufacturers with practical guidance to succeed in the European market
Richard and Amie at a glance...
- 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 listeners:
- 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