Medical Device Software: Complying with the MDR & FDA Regulations
Course
In The Rembrandt Hotel, London and London
Description
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Type
Practical seminar
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Level
Intermediate
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Location
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Class hours
8h
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Duration
2 Days
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.
Facilities
Location
Start date
Start date
Start date
About this course
BENEFITS OF ATTENDING:
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
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
Someone from admin will contact you regarding your enquiry/booking.
Reviews
Subjects
- Software specification
- Risk Management
- Architectures
- Usability and resulting design documentation
- Medical training
- Usability training
- Design
- Art
- Medical
- Risk
Teachers and trainers (2)
Koen Cobbaert
Chair COCIR Software Task Force
Peter Pringle
Consultant Engineer, Intertek
Course programme
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 ATTENDBENEFITS OF ATTENDING:
- 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
Medical Device Software: Complying with the MDR & FDA Regulations