FREE Webinar, Embedded Software in Medical Device: Common Regulatory and Quality pitfalls
About the training
Join us on Wednesday, September 28th at 2:00 PM Eastern Time as LNE/G-MED North America Inc. will be hosting a free informative session on Embedded Software in Medical Device : Common Regulatory and Quality pitfalls.
Software nowadays is a key component in healthcare industry. Medical device software, embedded in medical devices, can be found in several applications (network servers, smartphones, computerized information-handling system, imaging devices, …) and are intended for multiple purposes: Diagnostic, Therapy or Monitoring such as Infusion pump rate setting SW, Image processing SW, Radiation therapy planning SW, etc.
With increased use, the impact of software on the safety and performance of medical devices has also significantly increased over the years.
As part of a Medical Device, an embedded software is subject to the Medical Device Directives essential requirements. Besides the software development process, involving complex architecture, manufacturers have the obligations to ensure that the software that runs through their device is safe and effective for the patient and operator.
For Europe, there is a set of regulatory and quality insurance obligations and recommendations defined in Directives, Standards and Guidance Documents.
During the webinar, we will go over the following points:
- Important definitions and Descriptions
- What is an embedded software medical device in Europe?
- How to classify an embedded software?
- Use of harmonized standard EN 62304
- Which conformity assessment route for the CE marking of my software?
- Regulation and regulators approach
For the answers to these questions, and more, you can tune to LNE/G-MED North America’s upcoming Free webinar on Embedded Software in Medical Device: Common Regulatory and Quality pitfalls.
Mohamed Alsaadi Certification Project Manager /Lead Auditor for LNE/G-MED North America,Inc.
Mohamed holds a degree in Biomedical engineering, and joined LNE/G-MED 4 years ago in quality of Certification Project Manager and Lead auditor specializing within the electro-medical device scope and medical device software applications. Mohamed has been working with medical device manufacturers worldwide, auditing their regulatory and voluntary certification and on the European, Canadian and Brazilian Markets.