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Course Overview
Medical device software is evolving and growing exponentially. An increasing number of devices contain software as part of their makeup. Getting a software device to market and then maintaining it is extremely challenging. Once developed software is constantly changing to stay up to date with the latest operating systems or security issues. Notified Bodies and Regulators want to see how you are maintaining a high-quality product that puts the end user’s safety first.
This training course will provide you with solutions to the regulatory challenges you face when working with software as a medical device. Once completed, you will have the knowledge to know what must be done to meet Notified Body/ Regulatory requirements. You will briefly touch on aspects unique to software in major regulatory/development areas such as clinical evaluations, investigations, labelling, post market surveillance and risk management.
The course begins at the time stated at the top of the page
The course is broken up into modules outlined below
There will be breaks between modules
Session 1
28 February 2023 | 22 June 2023 | 9 November 2023
120 mins | 10:00 AM UK
Module 1: Software overview and definitions
Is your software a device?
Examine the definitions and intended use
Review the regulations
Module 2: Bringing medical device software to market
Examine the regulatory requirements to put a medical device software on the market.
Examine the Medical Device Regulation (MDR) and FDA systems
Engaging with a Notified Body
Controlling software suppliers and subcontractors
Software traceability
App stores and digital distribution platforms
Software recalls
Session 2
28 February 2023 | 22 June 2023 | 9 November 2023
120 mins | 1:00 PM UK
Module 3: Usability and Risk management for medical device software
Safety risk management – ISO 14971
Usability ISO62366
Applying an effective risk management strategy for medical device software
Design inputs
Module 4: Development of medical device software
Usability
Operating environments
Cyber security
Maintenance
Selection of tool chain
ISO62304, a practical approach
SAMD and embedded software
Document structure
Module 5: Maintenance strategies
Platforms and keeping up to date
Udi maintenance
Configuration management
What are significant changes
Post market considerations and regulatory maintenance
Post-market regulatory requirements
Implementation of Post Market Clinical Follow-up for medical device software
Successfully bringing together risk management, clinical evaluation and PMS to streamline ways of working
Richard Young has over 20 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.
Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.
Richard has worked on many software related projects for clients helping them achieve regulatory compliance in the EU. In addition, he has delivered both online and classroom training courses on medical device software. He can provide multiple examples and case studies during training, drawing on his extensive industry experience.
The course is designed for professionals who want to learn more about the regulatory requirements of medical device software products such as software-only products, hardware product with embedded software, health apps and medical device software.
These include:
Regulatory Affairs
Project and Product Management
Software Architects
Designers and Developers
Research & Development
Clinical Professionals
Usability Experts
Cybersecurity Experts
Risk Management Moderators
Quality and Regulatory Specialists
e-learning options
Want to train your team, department or whole organisation? This course can be developed into on-demand e-learning and hosted by Educo Life Sciences or on your own LMS platform.
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Complete our contact form by following the link. Get in touch.
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• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training
