VISAMED GmbH

In order to shorten the product development cycle, medical device manufacturers need to identify as early as possible the world-wide regulatory requirements for new or modified products. Until global harmonization is reached, it is important to develop supporting documents which are in compliance with European, Canadian and US requirements for product submissions.

VISAMED can assist you in

• Developing an effective regulatory strategy for Europe, Canada and US market clearance.
• Determining the applicability of the European, Canadian and US requirements/guidelines/standards
• Determining the European, Canadian and US Quality Systems requirements