Medical Devices QA Support

Medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer.

European Directive 93/42/EEC

TMQA can help you to understand and comply with these requirements, whether you are a sponsor, investigator, manufacturer, contractor or involved in any aspect of manufacturing.

Our experienced devices experts will provide you with the support, audit, advice and training necessary to ensure compliance in products you are manufacturing or others are manufacturing on your behalf.

TMQA’S Medical Devices Services

Development of Quality Management Systems (QMS)

  • Classification
  • Conformity Assessment Routes
  • Gap analysis

Technical File Review

Audit and Inspection

  • Preparation and Hosting Accreditation and Regulatory Inspections
  • Supplier Qualification Audits
  • Manufacturing Compliance Audits

Clinical Investigation Support

  • CIP compliance
  • ICF/PIS

Our experience covers start-up and commercial manufacturing in medical devices and IVDs.