Drug-Device Combination Products: Notified Body Opinion Process

    30 October – 1 November 2023, live online training


    This three-day course will give you a thorough understanding of the Notified Body application process as well as a comprehensive regulatory update. You will understand the responsibilities of the of Notified Bodies.

    Learning Objectives

    • Gain a comprehensive overview of the NB application process
    • Understand where the NB responsibility starts and ends
    • Design and development activities necessary for a successful NBO
    • Why EN ISO13485:2016 will help achieve a good submission
    • Understanding risks, requirements, and standards in the context of generating evidence of conformity
    • Using the GSPR checklist as a means to manage your design and development file

    Key Topics

    • Notified Body (NB) application & review process
    • Regulatory requirements (EU MDR)
    • EN ISO13485:2016
    • General Safety and Performance Requirements (GSPR)
    • CE marking

    Who should attend?

    This course is suitable for all those involved in:

    • Regulatory Affairs
    • Quality Control/ Assurance/ Engineering
    • Product Development/ Engineering/ Technology Transfer
    • Process Development
    • Research & Development

    Past participants

    • Global Head External Quality, Biogen
    • QA Manager, F. Hoffmann-La Roche
    • Senior Manager GLP/GMP, Merz Pharmaceuticals
    • Senior Technical Regulatory Affairs Manager, Idorsia Pharmaceuticals
    • Senior Technical Steward Devices, Novartis
    • Manager, External Manufacturing Management, Ferring 
    • R&D Engineer, Cook Medical
    • Principle Scientist Lead Combination Products, Lonza
    • Process Engineer, Novo Nordisk
    • Quality Manager, Boston Scientific
    • Global DRA Project Leader, Idorsia Pharmaceuticals
    • Design Team Manager, Owen Mumford
    • Development Engineer, Leo Pharma
    • Regulatory Affairs Manager, Novavax
    • Head of Regulatory Affairs, Vectura

    Our online training experience includes

    • Our client zone – a single source for all training materials as well as pre and post-training communication
    • Live interactive format via the Zoom platform
    • Direct interaction with the trainer
    • Q&As, case studies, polls
    • Revisit recorded sessions for 7 days
    • Training in digital format
    • Digital and LinkedIn certificates


    James Pink has over 20 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body.

    Drug-Device Combination Products: Notified Body Opinion Process

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 2 023 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate

    Price per delegate including:

    Online participation

    Recorded sessions for 7 days

    Online workbook & materials


    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori

    +421 222 200 543

    Training Details
    • Start Date
      30. October 2023
      02:00 PM Vienna time
      01:00 PM London time
      09:00 AM New York time
      06:00 AM Los Angeles time
    • End Date
      1. November 2023