Medical Device Software Development

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Medical Device Software Developmentin accordance with MDR/IVDR, IEC 62304 and 82304-1
Software as a Medical Device (SaMD) & Software in a Medical Device (SiMD)

Expert Lecturer: Mr. Vincent van der Meer

Categories: Bioforum International, Medical Devices, Regulatory Affairs

SKU: 251129

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In healthcare, besides hardware, there is an increasing development and application of integrated software (Medical Device Software or MDSW) and stand-alone Software as a Medical Device (SaMD).
These products are also subject to the regulatory requirements of the MDR and IVDR.
For the development of medical software, among other things, there are international standards that are also applied in Europe. By using these standards during medical software development, a software developer can ensure that the delivered product meets the legal requirements. This includes software development life-cycle principles and cybersecurity. This training covers both theory and practice, enabling you to make a substantial contribution to software development within the medical device field as an expert within your organization.

Dates:

19/05/2025
20/05/2025
26/05/2025
27/05/2025

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Course location: Virtual Course

Duration: 4 meetings, 2.5 hours each

Hours: 14:00 - 17:30

Credits: 2

Course Language: English

Course price: 4,950 NIS + VAT

Early registration discount until 11 May, 2025:
4450 NIS + VAT.

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Issues to be covered

Basic Principles of Software Development for MDR Compliance
- Qualification and Classification (MDCG 2019-11)
- Software Development Standards:
  - IEC 62304 – Process and Requirements
  - IEC 82304-1 – Process and Requirements
- Risk Management Integration
- SOUP & Legacy Software Considerations
- Software Release Process
- Feedback & Change Management
Module 1: Regulatory aspects of medical device software
Module 1.1 Introduction to CE marking
Module 1.2 Qualification and classification
Module 1.3 Conformity assessment and GSPR
Module 2: Software development
Module 2.1 Introduction to software development
Module 2.2 Risk and security management
Module 2.3 Software design and implementation
Module 2.4 Verification and validation
Module 2.5 Traceability and configuration management
Module 2.6 Feedback and change control
Module 3: Technical Documentation (bonus)
Module 3.1 Set-up of Technical Documentation

Who should attend

QA/RA professionals, Product developers at manufacturers, PRRCs, and anyone within companies developing SaMD or software as an integral part of equipment.

Benefits to the Participants

Participants will walk away:

With an in-depth understanding of essential regulatory frameworks and international standards (MDR/IVDR, IEC 62304, and IEC 82304-1)
Trained in the implementation of software development life-cycle principles like cybersecurity practices.
Equipped with practical skills to drive secure software development within their organizations.
With Integrated theoretical knowledge and how to practically apply said knowledge.

This training empowers trainees to significantly enhance their contributions to medical device software development, elevating the quality and regulatory adherence of their projects.

About The Lecturer

Vincent van der Meer

Studied life sciences (molecular biology) in Leiden, The Netherlands. Started