Medical Device Software: Complying with the MDR & FDA Regulations

An Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management

20-22 Nov 2019

& 28-30 Apr 2020 , 17-19 Nov 2020

GBP 1,849
EUR 2,589
USD 2,884

Book now

Course Overview

This course provides a comprehensive appraisal of the regulations and requirements that apply to medical device software worldwide. The seminar will be highly interactive, using real-life examples and state- of-the-art practices identified by Notified Bodies in Europe. There will be in-depth coverage on how to prepare compliant technical file documentation for medical device software products and a review of software specification, risk management, architectures, usability and resulting design documentation. In addition, there will be practical tips on how to streamline the development process, understand the regulatory requirements and how Notified Bodies review technical files.

There will be sessions on the practical implication of risk management and usability and an analysis of the differences between FDA guidance and MDR guidance on medical device software. Software recalls, the use of apps in medical devices, the implications of the new draft usability standard and advice on how to validate your system design will also be covered.

Why you should attend

  • Learn how to qualify and classify software in Europe and the rest of the world
  • Get in-depth understanding of the interpretations of MDR Classification Rules 10, 11, 12, 13, 15 and 22
  • Understand the implications of the MDR and US Code of Federal Regulations for software
  • Gain regulatory guidance on mobile apps, software as a service, cloud computing, artificial intelligence and continuous learning software
  • Learn how to write 510(K) and technical files
  • Get a practical understanding of quality management, design control and how it applies to agile software development
  • Hear the best practices on cyber security, risk management, usability andvalidation
  • Learn the principles of clinical evaluations for software as a medical device
  • Gain an insight into state-of-the-art standards applicable to software

Who should attend?

  • Senior management and project leaders
  • Software product managers, researchers, developers and clinical experts
  • Software development process managers
  • IT managers and integrators
  • Internal and external auditors and/or consultants
  • Regulatory affairs professionals
  • Quality system and quality assurance personnel
  • Technical and medical writers
  • GUI designers

Programme day one

Medical device software qualification and classification

  • MD and IVD definitions
  • Annex XVI products
  • In-vitro diagnostic software
  • Multi-functionality software
  • Cloud computing and software as a service
  • Intended purpose
  • Exempted functionality
  • Borderline with lifestyle and fitness software
  • Combination products – MD software to pharma
  • Population health and educational software
  • Drive or influence the use of a medical device
  • Quiz

Software classification – EU

  • Classification rules and the related definitions
  • Helsinki procedure and the borderline manual on qualification and classification
  • Implementing rules
  • Classification rules for active devices
  • Interpreting Rules 10, 11, 12, 13, 15 and 22
  • Classification under the IVDR
  • Case studies
  • Quiz

Classification according to the FDA

Bringing medical device software on the EU market

  • Go to market process MD and IVD
  • Go to market process combination products
  • In-house use by health institutions

Notified Bodies and the evidence they consider

  • Engaging with a Notified Body
  • Implementing a Quality Management System
  • Standards to consider
  • General safety and performance requirements
  • Technical file and clinical evaluation assessment
  • UDI number
  • Translations
  • Declaration of Conformity

Practical construction of a technical file

EUDAMED registration and distribution chain responsibilities

  • EUDAMED
  • Person responsible for regulatory compliance
  • Assuring the traceability of your software
  • Distributors, importers and authorised representatives
  • Controlling your suppliers and subcontractors

On the market

  • Complaint handling system
  • Medical incident reporting
  • Monitoring critical components or platforms updates
  • Post-market surveillance requirements
  • Unannounced Notified Body audits
  • Service updates, upgrades and other changes

Programme day two

Bringing medical software on the US market

  • US Code of Federal Regulations and its implications for software
  • Process and practical construction of a 510(K)
  • A case study

Rest of the world (Brazil, Canada etc.)

Standards and their implementation – a software perspective

  • ISO 14971 Risk management
  • IEC 62304 and IEC 82304 Software lifecycle and safety
  • IEC 60601 Electrical equipment
  • IEC 62366 Usability of medical devices
  • EN ISO 15223-1/ /ISO 15223 Symbols
  • IEC 27000 etc. Security standards
  • User manuals

Fundamental principles design control

Design activities in detail

  • Project management, development planning and change management
  • Requirements management
  • Risk management
  • Clinical evaluation
    • IMDRF on clinical evaluation
    • FDA expectations
      • PACS, mobile apps
      • Clinical decision support
      • Computer-aided detection and diagnosis
    • MEDDEV on clinical evaluation
  • Architecture and design
  • Development
  • Configuration management
  • Verification and validation
  • Usability

Presenters

Peter Pringle (20-22 Nov 2019)

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 confrontation 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.

Koen Cobbaert (20-22 Nov 2019)

Koen Cobbaert is quality and regulatory manager at Philips Healthcare. He represents COCIR in numerous work groups at European level. COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electro-medical industries. In 2009 COCIR created its software task force, which Koen has been chairing ever since. He put on paper the first draft of the qualification decision tree, which was later successfully adopted by the Member States in “MEDDEV 2.1/6 on the qualification and classification of standalone software”. Under Koen’s leadership COCIR’s software task force has contributed to the 1st and 2nd edition of this MEDDEV and has proposed the IMDRF work item on software as a medical device, which ultimately lead to IMDRF guidance on the qualification, risk stratification and clinical evaluation of software as a medical device. Currently Koen’s work focuses on drafting the European guidance for classification of medical device software, which is expected to clarify among others the use of classification rule 10 and 11 under the Medical Device Regulation (MDR).
Koen wrote several COCIR papers on a variety of software-related topics under the MDR: qualification of and responsibilities for rules engines, programming and runtime environments and libraries for dataflow programming and machine learning, economic operator requirements for app stores and digital marketplaces, significant changes of software, UDI numbers, etc.Via COCIR’s standards focus group he contributed to the development of IEC 82304 on safety requirements for health software and IEC 62304 on software lifecycle processes. Koen co-authored the FAQ on IEC 62304, which has been translated in several languages. Via COCIR’s North American sister organisation MITA he also contributed to several FDA guidance papers, including the guidance papers on patient and clinical decision support systems and on computer-assisted detection devices applied to radiology images and radiology device data.
Koen has over 15 years of hands-on experience in establishing regulatory strategies, writing technical files and 510(k)s, performing worldwide regulatory submissions and moderating risk management and clinical evaluation discussions for software applications for general radiology, oncology, neurology, cardiology and orthopaedics, computer algorithms for pattern recognition, computer aided detection, reasoning engines, decision support, clinical pathways, general systems such as HIS, LIS, IVD, PACS, EPR and mobile apps. He has a Master in Risk Management and Electrical Engineering.

Suzanna Kwade (20-22 Nov 2019)

Zuzanna Kwade is Medical Affairs Manager, Agfa Healthcare. Zusanna holds a PhD in Biochemistry and has more than ten years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research.

Since 2016, she has been actively involved in Clinical Evaluations according to MEDDEV 2.7.1 (Rev.4) for multiple devices, including high risk hardware devices and medical software. She also represents COCIR in the European Union Task Force on clinical evaluation of software.

Book now

20-22 Nov 2019
20-22 Nov 2019 DoubleTree by Hilton London-West End, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now
28-30 Apr 2020
28-30 Apr 2020 Venue not yet confirmed
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.
17-19 Nov 2020
17-19 Nov 2020 Venue not yet confirmed
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

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Previous customers include...

  • Bespak Europe Ltd
  • Boston Scientific
  • Cochlear Limited
  • Crux Product Design
  • DCA Design International
  • Debiopharm International SA
  • Dentsply Implants
  • Estonian National Institute for Health Development
  • GlaxoSmithKline (GSK)
  • GSK Consumer Healthcare
  • Inpeco SA
  • MED-EL Medical Electronics
  • Medela AG
  • Medicines and Medical Devices Agency of Serbia
  • Mobidiag
  • Mundipharma Research Ltd
  • NeuroDerm
  • Omron Healthcare
  • Omron Healthcare Europe BV
  • Perspectum Diagnostics
  • RDT Ltd
  • Roche
  • Sagentia Limited
  • Saudi Food and Drug Authority
  • Smart Process Solutions Ltd.
  • Teledyne DALSA
  • Teva UK Limited
  • TomTom International B.V.
  • UCB
  • Vision RT Limited

Koen brought a lot of practical industry experience which was extremely useful.

Leon Doorn, Sr. QA/RA Manager, Aidence B.V.

A well structured, well presented programme

Peter Ogrodnik, Professor of Biomedical Engineering, Keele University

The speakers were knowlegdable and interesting.

Cecile Boyer, Senior Quality Project Manager, Novartis Pharma AG

Good course. A lot of information in detail.

Jose Fernandez, Certification Manager, McLaren

Excellent content - good choice of speakers

Malgorzata Wilinska, Research Associate, University of Cambridge

Very good presentation

Massimo Panonzini, , Inpeco SA

It was great that both speakers had an understanding of what devices IBA makes and they tried to give suitable answers for our case

Inez Wathion, Verification & Validation Officer, Ion Beam Applications SA

Very good

Robert Gay, Senior Regulatory Affairs Manager - External Products and Software, Cochlear Limited

Very good, I would recommend this course for beginners and advanced levels

Arnaud Biermann, Senior Manager Regulatory Affairs, Anteis SA

The presentations in the folders did not follow the order that was presented by the speakers. Always best to check beforehand with the speakers the order of information as ideally it should match of presentation. This meant we were all looking for the slides whilst the speakers had started, meaning we often missed some important points.

Priti Darjee, Associate Director Regulatory Affairs, UK, Teva UK Ltd