Medical Devices QA Support
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
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.
