How to classify and obtain CE mark and FDA clearance of standalone medical device software

M. Cyrille Michaud
Durée de la formation
1 day
Compétences visées
With emerging technologies like mobile Health (mHealth), intelligent or communicating devices, software undertakes a large part of functionalities of most recent devices. Many firms feel that they are not prepared to have their processes about software audited by regulatory agencies.

Software is incredibly more present in medical devices now than 5 to 10 years ago. The path to get the CE Mark or FDA clearance for software medical devices can be long. It can also dramatically be shortened with the right decisions and good information.

Knowing the key steps and the pitfalls in your way to obtain the CE Mark is a factor of success for medical devices start-ups.
Public ciblé
People working for medical devices or in vitro diagnosis manufacturers:

CTO or CEO of start-ups,
Quality Assurance and Regulatory Affairs Managers,
Software Project Managers,
Software Development, Risk Management, and Test Engineers.
Objectif de la formation
Learn about CE regulatory framework: 93/42 CE directive, CE guidances.
Learn about US regulatory framework: 21.CFR, Food and Drug Administration (FDA).
Learn harmonized standards: ISO 13485, ISO 14971, IEC 60601-1, IEC 62304 …
Learn what activities are required: software design, software maintenance.
Learn how the obtain the CE Mark and FDA clearance.
Worldwide overview of Regulations,
The CE Mark and the CE Directives,

The 21.CFR and FDA regulations,
Application to software medical devices,
ISO standards for software medical devices,

Paths to Clearance and CE mark.

An example with a software product will be used to illustrate the concepts described during the course.