This seminar will be held in English.
During the seminar, the standards IEC 62304:2006, standards IEC 62304-1:2015 Amendment 1 and IEC 82304-1:2016 and other international regulations will be presented in a practical manner. The implementation of these software standards is a challenge for many manufacturers of medical devices – especially for newcomers and start-ups – as a whole range of partly new processes is required. You will get a basic overview of the essential contents of the standards with the required processes that describe the software lifecycle.
In this seminar you will learn the relevant standards, laws, regulations, guidelines and methods, for example how to implement your agile software development compliant with regulatory requirements, you will learn how to integrate third party software („SOUP`s“) into your medical device compliant with standards and how to document it.
By means of practice-relevant exercises, the handling of the standard will be deepened and the implementation with regard to process design and documentation will be practiced. The aim of the seminar is to learn the requirements for the development and approval of medical software and to be able to implement them for your own application.
This basic course is also suitable for participants with no or little previous knowledge. For newcomer and start-ups, this course offers an optimal introduction to the implementation of IEC 62304 and IEC 82304-1.
- Definitions of terms
- Overview of relevant regulations and standards and connection with other essential standards for medical devices
- Requirements of the software standard IEC 62304 (Software for medical devices – Software life cycle processes)
- Software Safety Classification
- Software-Development 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 in existing medical software (Legacy Software)
- Group work & exercises
- Early bird (until 4 weeks before the seminar): Euro 520,- (excl. VAT)
- Standard (starting 4 weeks before the seminar): Euro 590,- (excl. VAT)
- incl. seminar documents as PDF and a certificate of participation.
Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG
You only need a laptop with camera and microphone for our ONLINE seminars. Our eLearning platform works on all operating systems in the web browser. You will receive the seminar documents and the link to the virtual seminar room in time by email. The seminar will be interactive – similar to a face-to-face seminar: i.e. you can ask your questions to the lecturer, there will be exercise examples and also the possibility to exchange ideas with the other participants.