FDA regulators are increasing focus on medical device safety, risk management and reporting. 21 CFR Part 820, also known as the FDA Quality System Regulation (QSR), will be merged into and replaced with with ISO 13485:2016, an international standard for Quality Management Systems (QMS) of medical device manufacturers and providers.The revisions are intended to harmonize domestic and international requirements for device manufacturers. We help you:

 

·      Manage risks, prepare for FDA inspections and ensure standards compliance. 

 

·      Meet the requirements of a QMS for the design/manufacture of medical devices, including:

 

• Controls in work environment to ensure product safety.

• Risk management & design controls during production development.

• Requirements for Inspection/Traceability for implanted devices.

• Requirements for documentation/validation of processes for sterile medical devices.

• Requirements for verification of the effectiveness of Corrective and Preventative Actions (CAPA).

 

·      Comply with QMS requirements, including: Quality Policy, Quality Objectives, Quality Manual, Data Management, Processes, CAPA & Document Control.

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