European Assistance

These services are provided either directly by MD Ventures or through MD Ventures' European Associates. MD Ventures treats each contract service as a project and coordinates each project through a Project Plan which 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.

Quality Assurance Services:

• Gap Analysis - This is an overview of the establishment's current quality system and determination of missing or deficient elements needed to comply with the Medical Device Directive (MDD).
• Assistance with European MDD Compliance.
• Annual Internal Audits- This audit is sufficient to satisfy the ISO 9000 and EN 46000 internal audit requirements.

Regulatory Services:

• European Product Registration
• European Repres entative
• Product Testing
• Clinical Trials and Clinical Testing
• Assistance with product CE mark
• Interface with Notified Body

Engineering Services:

• Product Design
• Product Improvement
• Product Validations
• Process Validations

European Marketing and Distribution:

• Warehousing
• Identification and Liaison to Distribution Partners

 

 

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