Combination Products: Notified Body Opinion Process

        Drug-Device Combination Products: Notified Body Opinion Process

        24 – 26 March 2026

        1 850 €

        TRAINING TIMES

        13:00 - 16:00   Vienna

        12:00 - 15:00   London

        08:00 - 11:00   New York

        05:00 - 08:00   Los Angeles

        Online training - Wi-Fi icon

        WHY SHOULD YOU ATTEND?

        Navigate the Notified Body Application Process with Confidence

        Understand each step of the NB review process, responsibilities, and expectations to strengthen your submissions.

        Stay Ahead on EU MDR and ISO 13485 Requirements

        Get up to date with the latest regulatory framework and learn how EN ISO13485:2016 supports compliance.

        Build Robust Design & Development Files

        Use the GSPR checklist and proven strategies to manage risks, generate evidence of conformity, and prepare high-quality documentation.

        Achieve Successful CE Marking

        Gain the practical tools and regulatory insights needed to streamline approval and ensure market access for your medical devices.

        OUR ONLINE TRAINING EXERIENCE INCLUDE

        Live, Interactive Format

        Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.

        Full Access via Client Zone

        All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.

        Certificate of Completion

        Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.

        LEARNING OBJECTIVES

        Notified Body Application icon

        Notified Body Application

        Gain a comprehensive overview of the application and review process. Understand where the responsibility begins and ends.

        Standards icon

        Standards

        Apply ISO 13485 and 11608 to achieve a good submission

        General Safety and Performance Requirements icon

        General Safety and Performance Requirements

        Using the GSPR checklist to manage your design and development file

        Generating Evidence icon

        Generating Evidence

        Understanding risks, requirements, and standards in the context of evidence

        Design Control icon

        Design Control

        Design and development activities necessary for a successful NBO

        WHO IS THIS TRAINING FOR?

        Regulatory Affaris

        Quality Assurance & Control

        Device Engineering & Manufacturing

        Research & Development

        KEY TOPICS

        Notified Body application & review process

        Design and Development File

        CE marking

        Regulatory requirements: EU MDR, Annex 1, IVDR

        ISO 13485 & ISO 11608

        General Safety and Performance Requirements

        TRAINER

        James Pink
        Meet James Pink — a seasoned regulator and recognized authority in quality and risk management for medical devices. With over 25 years of experience, he played a key role in establishing one of Europe’s leading notified bodies. During the COVID-19 pandemic, he was also responsible for scaling up the UK’s national ventilator effort.
        TESTIMONIALS
        RA Specialist, Becton Dickinson
        James' knowledge is impressive, and the white board makes it interactive and alive
        RA Specialist, Molex
        I am very satisfied with the course. The training was extremely valuable, and James's expertise and ability to convey information clearly made the experience engaging and informative. I particularly appreciated the use of real-world examples, which helped contextualize the material and enhance understanding.
        Regulatory Affairs Manager - New Projects, Q-Tec Group
        It was just fantastic!

        PAST PARTICIPANTS

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        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.

        Share This Event
        Online Participation
        1 850 € Price incl. VAT: 1 850 €

        Price per delegate including:

        Online participation

        Online workbook & materials

        Certificate

        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.

        Laura Kristensen

        laura.kristensen@symmetric.events
        +421 222 200 543

        Event Details
        • Start Date
          24. March 2026 13:00
        • End Date
          26. March 2026 16:00
        • Email
          laura.kristensen
        Request in-house