Date: Wednesday, August 23, 2017
Time: 11:00 AM Eastern Daylight Time
Duration: 1 hour
In order to ensure patient safety, constantly emerging technologies and product innovations require regulators and standard development organizations to permanently advance and adapt existing standards to the latest state of technology.
A basic standard for all medical devices is the EMC (Electromagnetic Compatibility) standard 60601-1-2. This standard has been published in its latest version, the 4th Edition, in 2014 (IEC, EN 2015) and will be a mandatory requirement for all medical device manufacturers after expiration of the transition period. Not only are there fundamental differences to the previous version of the standard (60601-1-2, 3rd Edition), the transition period for Europe and North America has also been determined to end after December 31, 2018 already. Therefore, medical device manufacturers are strongly advised to inform themselves as soon as possible of the respective changes and take these into account during the development of new products as subsequent design adjustments are usually too complex, time-consuming and costly.
CSA Group’s Webinar on the new EMC Standard 60601-1-2 4th Edition prepares medical device manufacturers for the coming changes and answers important questions such as:
- What should be considered during product development?
- Which new requirements do I have to meet and what are the “highlights” of the updates?
- What are the differences to 60601-1-2 3rd Edition?
- Which products are mostly affected by the new standard?
- What happens to existing certified products?
- What is the timeline for the changes with regard to accessing different markets such as North America or Europe?
Register now and secure expert knowledge from one of the leading testing & certification organizations in North America.
Product development professionals, quality managers, R&D professionals, design and compliance engineers and regulatory affairs professionals from medical equipment manufacturers
Overview of the high level changes to the 60601-1-2 standard, and the impact it will have on the testing and certification process for a Medical Device manufacturer.
Highlight what a manufacturer needs to be prepared for before they can start testing, especially the new role Risk Management and Essential Performance play in the testing process.
Costs: Free of charge
Speakers: Naysahn Saeed, CSA Group
Naysahn Saeed has been working for CSA Group since 2008, certifying medical devices around the globe. He has developed and delivered several trainings to multiple audiences on medical device safety and risk management in the U.S., Europe, and Asia. Prior to his time at CSA Group, Naysahn worked for a division of GE Healthcare, where he took on Risk Management responsibilities as the company went through FDA audits as a result of a Consent Decree. Naysahn is also a qualified Technical Assessor within the IECEE CB Scheme.