This In-house course provides an Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management
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.
Your team will:
DAY 1: The Regulatory Framework
9:30 Introduction and WelcomeGeneral Principles and Background Information
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
Rest of the World (Brazil, Canada, …)Future Regulations
Day 2: Design Aspects of Medical Software9:00 Regulations and Standards
12:30 Lunch13:30 Practical Implementation
A case study
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 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.