Medical Device Software: Complying with the MDR & FDA Regulations

This In-house course provides an Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management

Course Overview

This In-house course will provide a comprehensive introduction to the regulations and requirements that apply to Medical Device Software. The seminar will be highly interactive, using real life examples and state-of- the-art practices identified from Notified Bodies in Europe. How to prepare compliant MDD Technical File documentation will be explained for Medical Device Software products.

Software specification, risk management, architectures, usability and resulting design documentation will be discussed. In addition, practical tips on how to streamline the development process, understand the regulatory requirements and how Notified Bodies review Technical Files will be covered.

Day two of the In-house course will go into more depth and will focus on practical implication of Risk Management and usability, and will look in detail at the FDA guidance on Medical Device Software compared with the MDD guidance. Software recalls will be discussed, the use of apps in medical devices as well as the implications of the new draft Usability Standard. Practical advice on how to validate your system design will also be addressed.

Why Your Team Should Do The Course

Your team will:

  • Understand the Regulatory Framework
  • Comply with the MEDDEV on Stand Alone Software
  • Know the Principles to Bring a Medical Device Software Product to the Market
  • Review the Practical Construction of a Technical File
  • Be Aware of the US Code of Federal Regulations and its Implications for Software
  • Gain FDA Guidance on Medical Device Software Systems and Mobile Apps
  • Receive Key Information on Design Aspects of Medical Software
  • Review the IEC and EN ISO Standards and their Applicability; including Risk Management and Usability
  • Understand the Fundamental Principles of Quality Management & Design Control
  • Clarify Design Activities; including Architecture & Design, Configuration Management and Verification and Validation

What Team Would Benefit

  • Senior Management, Project Leaders
  • Internal / External Auditors and/or Consultants
  • Regulatory Affairs
  • Quality Systems and Quality Assurance Personnel
  • IT Managers
  • New Product Development, Marketing
  • Software Product and Process /Manufacturing Engineering Staff
  • Document Control / User Manual Writers
  • R&D Software Engineering Team Members and GUI Designers

Sample Programme Day 1

DAY 1: The Regulatory Framework

9:30 Introduction and Welcome

General Principles and Background Information
  • Medical Device Directive 2007/47/EC, Directive 98/79>EC and its implications for software
  • MEDDEV on stand-alone software
  • ISO 13485 Medical device quality management systems

General Principles to Bring Medical Software on the Market

The Role of Standards Related to Medical Software

Essential Requirements, Technical Files, Declarations of Conformity

Audits and Inspections

12:30 Lunch

13:30 Practical Construction of a Technical File

US Code of Federal Regulations and its Implications for Software

Practical Construction of a 510(k)

FDA Guidance on
  • Medical device data Systems, middle ware and PACS servers
  • Mobile apps
  • Clinical decision support
  • CAD engines

Rest of the World (Brazil, Canada, …)

Future Regulations
  • Impact of Medical Device Regulations in Europe
  • Impact of FDASIA on FDA policy
  • Impact of IMDRF work on Software as a Medical Device on regulations worldwide

Sample Programme Day 2

Day 2: Design Aspects of Medical Software

9:00 Regulations and Standards
  • IEC 62304:2006 Software Life Cycle Processes + second edition
  • IEC 82304 Health Software – Part 1: General requirements for product safety (future)
  • IEC 60601-1 Edition 3 Medical Electrical Equipment
  • ISO 14971 & ISO 24971 Risk management IEC/TR 80002 -1
  • IEC 80001 Risk management of IT networks
  • IEC 62366 Application of usability to medical devices + second edition
  • EN ISO 15223-1 Symbols
  • ISO/IEC 27001 Cybersecurity
  • Unique Device Identifier

12:30 Lunch

13:30 Practical Implementation
  • Fundamental principles of Quality Management & Design Control
  • Development models/lifecycles
  • Design activities in detail
    • Project Management, Development Planning & Change Management
    • Requirements Management
    • Risk Management
    • Architecture & Design
    • Development
    • Configuration Management
    • Verification and Validation
  • Tools

A case study

Recommended Trainers

Janette Benaddi

Janette Benaddi is an Independent Consultant and previously Director of Clinical & Consulting Europe for NAMSA. NAMSA is a global Medical Research Organization offering a breadth of services form preclinical to post market activities throughout the medical device product development cycle.

She has over 20 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. She has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.

She is a registered nurse, has a BSc in Management studies, a Diploma in Company Direction and a Diploma in Management studies, she holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. She has published several articles relating to medical device regulation and clinical studies.

Koen Cobbaert

Koen Cobbaert is chair of COCIR’s software task force, COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries. In that role he co-authored the first and second edition of MEDDEV 2.1/6 on the qualification and classification of standalone software and is today co-authoring the software classification guidance for Rule 10 and 11 under the Medical Device Regulation. In that role Koen also co-authored the FAQ on 62304:2006. In his day to day job Koen works for Agfa Healthcare as regulatory affairs and quality assurance professional in the development of software applications for use in general radiology, nuclear medicine, cardiology and orthopaedics. He has submitted a variety of technical files and 510(k)s for software-only medical devices. He guards process compliance for solution development processes and is himself responsible for managing Agfa’s risk management, clinical evaluation and regulatory monitoring process. Koen has a master in electrical engineering and risk management.