Introduction to the development of software for medical devices
The development of standalone software such as mobile medical applications, as well as the integration of software as a component in medical devices, presents a complex challenge for many medical device manufacturers – at the intersection of technology, regulations, and clinical evidence.
This in-house seminar provides your employees with an overview of the regulatory framework and familiarizes them with the specific aspects of placing medical software on the market. Practical and up-to-date examples illustrate the classification and conformity assessment requirements for medical software in the most important markets.
Employees will learn about all phases of the product lifecycle of medical software – from development and initial market placement to software maintenance (including updates and bug fixes). We explain what is important when placing software on the market in key regions and how the required processes can be effectively integrated into the quality management system.
The seminar contents
Regulatory Basic Requirements in Europe and the USA
- Comparison / Overview of Regulatory Frameworks for Medical Softwar
- Decision-making aids for the classification of software as a medical device
- Besonderheiten von Standalone inkl. Mobile Medical Applications ( „APP“) and Embedded Software
- Classification principles for medical software
Practical examples and conformity assessment procedures
- Practical examples and borderline cases
- Classification of medical software in Europe
- Systems (When does a PC or mobile phone become a medical device?)
- Notified Body & the Conformity Assessment Procedure:
- Evaluation of technical documentation
- Quality Management Audits: ISO 13485
Selected requirements
- Product development processes
- Topical excursions
- Agile development processes
- Requirements engineering
- EU Regulations MDR / IVDR – General Safety and Performance Requirements
- Clinical evaluation / Clinical data
- Resources, labeling, outsourced processes (app stores)
- Corrective and Preventive Actions (CAPA) versus problem-solving process
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
