Regardless of the market for your medical device, there are regulatory and compliance concerns that you must address.
CQ authors regulatory submissions, such as FDA 510(k) submissions and CE mark technical files. We see these submissions all the way through, ensuring your products gain regulatory market clearance.
On the compliance side, our knowledge and experience with FDA inspections and ISO audit should be an asset to your company.
Here are some of the Regulatory and Compliance services we provide:
- Support during FDA inspections and ISO audits. Serve as the “face” of your company with auditors.
- Assist with FDA 483 observations, FDA warning letters, and ISO observations. Establish corrective action plans.
- Correspond with regulatory agencies.
- Assist with design history files (DHF), 510(k) submissions, technical files, and other regulatory submissions.
- Ensure product risk management practices and documentation are compliant and streamlined.