Two Day Introduction to Medical Device Software Course: Regulations and Requirements (London, United Kingdom - November 28-29, 2017) - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "An Introduction to Medical Device Software: Regulations and Requirements" conference to their offering.

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.

Agenda:

Programme Day One

Day 1: The Regulatory Framework

9:30 Introduction and Welcome

General 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

12:30 Lunch

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

Rest of the World (Brazil, Canada)

Future Regulations

Programme Day Two

Day 2: Design Aspects of Medical Software

9:00 Regulations and Standards

12:30 Lunch

13:30 Practical Implementation

A case study

For more information about this conference visit http://www.researchandmarkets.com/research/wrjs92/an_introduction

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T. Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T. Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices