A practical approach from Notified Body and Industry Experts
This 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 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 you should attend
- 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
Programme Day One
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
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, …)
- 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
Programme Day Two
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
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
- Configuration Management
- Verification and Validation
A case study
Agfa HealthCare ,
Koen Cobbaert is chair of COCIR’s software task force. He is one of the authors of the first edition of MEDDEV 2.1/6 on standalone software and the FAQ on 62304:2006.
In his day to day job he works for Agfa Healthcare as regulatory affairs and quality assurance professional in the development of software applications for use in the fields of general radiology, nuclear medicine, cardiology and orthopaedics.
He has a masters in electrical engineering and risk management and manages Agfa’s product safety risk management process.
PES Reigate ,
MDD & ISO 13485 Consultant
Peter Pringle is a consultant with international hospital experience; he has managed projects in installation, process and software. His medical software experience brings a unique understanding of the quality systems and configuration control that is required to make a project right first time.
He has the ability to focus and create a vision, interact and motivate at all levels while not afraid of confutation and accepting responsibilities. He enjoys the challenge of empowering people to be accountable for their tasks bringing about the ability to see the big picture in a very short space of time.
Since May 2000 he has operated as an independent (Accredited Business Link & MHRA) consultant. He has established an expertise in developing project proposals and stimulating co-maker and e-business relationships with many companies, also developing and submitting major project proposals for several clients with considerable success. From 1986 to 2000 he worked in the Radiotherapy division of Philips Medical Systems (purchased by Elekta of Sweden) whose main products consist of a range of computer controlled linear accelerators for the treatment of cancer.
He has worked extensively in Scandinavia, Germany, Italy, Russia, USA and Great Britain. With this experience he can bring a very personal view of project processes, interpretation and implementation to any forum, together with a unique ability to focus a team on the objectives and goals that are required by the sponsor of the project.
Peter is qualified in ISO 13485 / 9000 / 14000 / 14971 and prepares FDA pre audits, establishing technical documentation for product compliance to the Medical Device Directive, he also advises companies on software development procedures and documentation.
- 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
Hilton Green Park Hotel
Half Moon Street
Just a 5 minute walk from Green Park (Piccadilly, Jubilee and Victoria lines) and a 7 minute walk from Hyde Park Corner (Piccadilly line)
Victoria station is the closest National Rail Station - however the hotel is accessible from all London Stations via the underground
Carrington Street NCP (3 minutes walk to hotel) - Carrington Street, Shepherd Market, London, W1J 7AF.
Chesterfield House NCP (3 minutes walk to hotel) - Chesterfield Gardens, Shepherd Market, London, W1J 5JU.