2019 IEC 62304 Seminar - Medical Device Software - Life Cycle process, SaMD consideration and Cybersecurity

Topics will include

  • Overview of Regulatory recognition of the IEC 62304 Standard
  • Review of the 5 key Process for software lifecycle described in the standard
  • Introduction of FDA SaMD guidance: Clinical Evaluation
  • US FDA Cybersecurity requirements with UL 2900

May 29, 2019

  • 11 Slim Barracks Rise
    (off North Buona Vista Road)
    138664
    Singapore

Overview

Cyber breached, hacked, data leakage are much more significant threat to internet Medical device regulators are putting eyes on preventing cybersecurity compromising. As known, Software validation is one of the essential factors to ensure device safety and effectiveness. IEC 62304 has long been recognized internationally for developer to comply. IMDRF recently publish a guidance which call for more stronger linkage between software results with clinical validity. This seminar will focus on discovering IEC 62304, content of Software as Medical Device, and Introducing UL 2900 as a recognizes consensus standards for cybersecurity

At the end of this full day session, you will learn a better overview of IEC 62304, as well as the relationship with SaMD, and how UL 2900 can help you comply with cybersecurity requirement from pre-market and post-market perspective

You will receive a confirmation reminder one week before the event. If you find you cannot attend, please reply to your registration confirmation email to cancel your registration.

PRESENTERS

  • Tim Lin

    Senior RA/QA Consultant for Emergo, and previously worked as technical file reviewer at the Taiwan Regulatory Authority (TFDA).  He has in depth of RA/QA knowledge & hands on review experiences in active/non-active device and IVD.

    He has also vast experienced in product developmental cycle, quality management system consultation, including software development per IEC 62304; usability engineering per IEC 62366, and risk management per ISO 14971; as well as regulatory affairs consultation in multiple countries - 510(k); CE MDD; China FDA and Taiwan FDA. He has successfully supported several established organizations in their quality system, and conducted relevant activities to demonstrate compliance. He has been invited to speak at several international Regulatory Affairs conferences around the APAC region.