Medical device regulatory consultancy IMed will run a series of webinars explaining how manufacturers can take their products to the US market.
IMed has seen an uptick in requests for support with entering the US market as the regulatory environment in the European Union and UK remains unclear, and the company says it has noticed that companies perceive dealing with the Food and Drug Administration (FDA) as a daunting prospect.
There is step-by-step guidance on the FDA website to tell manufacturers exactly what to do. The FDA expects guidance to have been followed properly and for manufacturers to be well prepared, but IMed says the regulator is generally both pragmatic and helpful during the approval process.
IMed says it wants to help remove the, often self-imposed, barriers to US regulatory approval for manufacturers and so are launching a series of US market access focused webinars, starting on 18th May.
The consultancy’s technical director Tim Bubb and Kevin Malacek from the ‘Mentor Means Business’ trade organisation in the City of Mentor, Ohio, will be giving manufacturers their first glimpse of the US Medical Device and IVD approvals process.
You can find more information about the webinar series, here.
IMed will be exhibiting at Med-Tech Innovation Expo alongside Health Tech Enterprise on 7-8 June on Stand C59. Register for FREE at www.med-techexpo.com.