Regulatory Compliance

Retained Services: For an annual retainer, MD Ventures offers local Regulatory and Quality Assurance representation providing these and other service for your company. Fees are determined by the scope of the work and the number of contracted hours.

US Agent: Effective February 11, 2002, FDA requires foreign manufacturers to designate a person residing in the US as their US Agent responsible for:

• Assisting FDA in communications with the manufacturer
• Responding to questions concerning products being offered for import into the US
• Assisting FDA in scheduling inspections

Official Correspondent: The owner or operator of the medical device establishment designates this person to be responsible for the following FDA required activities:

• Completing Annual Establishment Registrations
• Maintaining contact with FDA for Device Listings
• Maintaining and submitting a current list of officers and directors to FDA upon request
• Receiving pertinent correspondence from FDA directed to and involving the owner or operator of the foreign manufacturing company
• Certification of Medical Device Reports to FDA annually

Additionally MDVentures can fulfill FDA requirements and act as your local regulatory/Quality Assurance representative for maintenance of customer complaints and submission of Medical Device Reports.

Contract Services: Each contract service is treated as a project and is controlled through a Project Plan that identifies all major milestone activities and deliverables necessary to complete the project. The Project Plan is updated as the project proceeds and is used to control project costs and timelines.

• Regulatory Strategies
• Product Testing
• Clinical Testing
• Product Submissions

 

To find out how MDVenturescan provide solutions for your company
call (909) 506-2674 or email: solutions@mdventures.net