Regulatory Affairs

Medpole will provide regulatory support prior and after product market release:

· Act as Authorized Representative

· Communication with Notified Bodies

· Expertise in local regulations

· Competent Authorities submission/notification

· Ensure compliance to European standards and Directives

· Conduct audits

Medpole will help you to develop the most appropriate and fastest regulatory strategy to market approval in Europe:

· Identify applicable Directives and Standards

· Select Notified Bodies

· Select path to approval

Support

Strategy