DUBLIN--(BUSINESS WIRE)--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.
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
13:30 Practical Construction of a Technical File
US Code of Federal Regulations and its Implications for Software
Practical Construction of a 510(k)
Rest of the World (Brazil, Canada)
Programme Day Two
Day 2: Design Aspects of Medical Software
9:00 Regulations and Standards
13:30 Practical Implementation
A case study
For more information about this conference visit http://www.researchandmarkets.com/research/wrjs92/an_introduction