Quality Assurance

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.

US 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 FDA Quality System Requirements (QSR).
• Assistance with FDA QSR Compliance
• Annual Internal Audits - This audit is sufficient to satisfy the QSR and ISO 9000/EN46000 internal audit requirements.

European 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.

 

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