IMed Launches Advice Webinars for US Market Access

As the regulatory landscape in the EU and UK continues to be ambiguous, IMed has noticed an increase in calls for assistance when trying to break into the US market. They also say that a lot of businesses see working with the FDA as an intimidating challenge.

On the FDA web page, there is a simple guide that outlines precisely what businesses need to do. The organisation demands strict adherence to instructions and total preparedness from producers, but according to IMed, they are typically practical and supportive during the clearance process.

Next week, IMed plans to start a series of webinars focused on US market entry in order to help companies overcome the frequently self-imposed obstacles to receiving US FDA clearance.

The launch episode will give manufacturers an initial look into the US Medical Device and IVD clearance procedure with the FDA’s technical director Tim Bubb and Kevin Malacek from the ‘Mentor Means Business’ trade group.

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