Process Design, Scale-up and Technology Transfer for Medical Devices

    18 – 20 October 2021, online training


    This interactive 3-day training will provide you with practical tools and knowledge for process risk assessment during scale up and technology transfer of medical devices. You will receive an in-depth update on the regulatory landscape, presented interactively through case studies involving injection moulding (cannulas), metals processing (orthopaedic implants) and electronic assembly (IC boards).

    Who should attend?

    This course is designed for those involved with quality assurance, regulatory, engineering, manufacturing in medical device design, development and manufacturing.

    • Quality Managers & Engineers
    • Medical Device Engineers
    • Manufacturing Engineers
    • Process Engineers
    • Validation Managers, Engineers and Technicians
    • R&D and Product Development Managers, Engineers and Scientists

    Learning Objectives

    • 10 Steps to understanding and controlling risk
    • Navigate the complex medical device regulatory landscape
    • Understand acceptance criteria
    • How to control risk through GMP
    • Understand the meaning of generally acknowledged state of the art
    • Build transparent and methodical processes to achieve commercial-scale production

    Key Topics

    • EU MDR 2017/745 regulatory requirements
    • Quality system regulation
    • Statistical methods in design and process
    • Quality by design Principles
    • International standards (ISOs; 13485, 14971)
    • Risk evaluation and risk acceptability
    • Quality requirements and suppliers
    • Benefit-risk determination
    • Production and postproduction activities
    • Usability, cybersecurity, risk & QMS and resources


    • 3 days of interactive learning
    • Exchange experience with colleagues
    • Training materials in digital format
    • All delegates will receive digital & LinkedIn certificates


    Health Sciences and Medical Devices Consultant
    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.
    Online Participation
    1 450 Price incl. VAT: 1 450

    Price per delegate including:

    Online participation

    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.

    Lydia Makori
    +421 222 200 543

    Training Details