View: Please click this link to view the webinar.

Duration: 60 minutes

Available On Demand

Summary:
To remain relevant in the long term, businesses need to look beyond one single national market.

As the largest medical device market in the world, North America remains a key target region for manufacturers. Growing regulatory scrutiny makes entering the North American market a complicated and time-consuming endeavor. There are several things that need to be considered, which are fundamentally different to accessing other markets and manufacturers of medical devices need to maneuver themselves through a jungle of regulations, standards and institutions.

To be able to access a foreign market quickly and without any delays, it is necessary for manufacturers to understand essential market access requirements of their key regions and work with a knowledgeable and experienced partner.

In our webinar, you will learn about the current regulatory situation in Europe compared to the U.S. and Canada. You will understand the legal requirements and necessity of product certification in North America and receive clear insights into the differences of the product approval processes of the U.S. and Canada.

Register to watch the recording and secure in-depth information from one of the leading testing & certification organizations in North America.

Language: English

Target Group: Product development professionals, quality managers, R&D professionals, design and compliance engineers and regulatory affairs professionals from medical equipment manufacturer

Content:

– Current regulatory situation EU vs. US & CAN
– Necessity of product certification and legal requirements in North America
– Differences in the product approval process in CAN & US

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.

View: Please click this link to view the webinar.