QRA Consulting Services

Global Regulatory Compliance for Medical Devices

As a medical device consulting firm, we have successfully prepared and submitted Technical Files, US FDA – Pre-submissions, De Novo applications, 513(g) and 510(k) submissions for medical device and IVD companies from around the world seeking to sell in the United States, Canada, Australia and other international markets

Quality Management Systems

Global Regulatory Compliance for Medical Devices

We can assist with your medical device regulatory needs. We help assure compliance with global regulations including FDA, MDSAP, Health Canada Regulations, ISO requirements, and other specific markets.

Design Control Project Management

Global Regulatory Compliance for Medical Devices

Design Control Project Management

We are proficient in developing a Design Control project guideline to bring the Medical Device from concept all the way to approved for market distribution following the least burdensome approach.

QRA Consulting Services

Global Regulatory Compliance for Medical Devices

Global Regulatory Compliance for Medical Devices

Global Regulatory Compliance for Medical Devices

Quality Management Systems

Global Regulatory Compliance for Medical Devices

Global Regulatory Compliance for Medical Devices

Design Control Project Management

Global Regulatory Compliance for Medical Devices

Design Control Project Management

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