Implementation of IEC 62304 and IEC 82304-1 for medical device manufacturers

As part of this in-house seminar the standards IEC 62304:2006, IEC 62304-1:2015 Amendment 1 and IEC 82304-1:2016 along with other international regulations, will be presentet in a practical and application-oriented manner. Implementing these software standards poses a challenge for many medical device manufacturers—especially for newcomers and startups—since they require a range of (partly new) processes.
Participants will receive a foundational overview of the key contents of the standards, including the required processes that describe the software lifecycle.

In this seminar, participants will learn about the relevant standards, laws, regulations, directives, and methods—for example, how to align their agile software development with regulatory requirements. They will also learn how to integrate and document third-party software (“SOUPs”) in compliance with applicable standards as part of a medical device.

Through practical, hands-on exercises, participants will deepen their understanding of the standard and practice its implementation with regard to process design and documentation. The goal of the seminar is to learn the requirements for the development and approval of medical software and to be able to apply them in one’s own practice.

The seminar contents

  • Definitions, terminology
  • Overview of relevant regulations and standards and their relationship to other essential standards for medical devices
  • Requirements of IEC 62304, the software standard for medical device software life cycle processes
    • Software safety classification
    • Software devolopement process
    • Software maintenance process
    • Software risk management process
    • Software configuration process
    • Software problem-solving process
  • Overview IEC 82304-1 (Health software — Part 1: General requirements for product safety)
  • Validation of medical device software
  • Implementation of the standard for existing medical software (legacy software)
  • Practical exploration of key aspects of the standard through group work

Costs

1 day in-house training: € 3,890 (excl. VAT) for max. 10 participants
incl. seminar documents and certificate of attendance, plus travel expenses

your trainer

DI Martin Schmid, Managing Director & Senior Consultant en.co.tec
Information about our trainers

Book now:

Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491