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Implement Medical Device Regulations

Keeping in compliance is an important aspect of the medical device industry. The United States Code of Federal Regulations, Title 21 Part 820: Quality System Regulation safeguards patients, and helps you maintain product quality.

Get and Stay in Compliance

Are you a medical device manufacturer that has been found out of compliance and cited by the Food and Drug Administration (FDA)? If your citation goes unaddressed, you can be audited. Eventually, the situation can escalate and the FDA may take enforcement action.

Noyce Quality Consulting LLC has the expertise and resources to come in and fix these problems quickly. We will help you get everything straightened out and get you into compliance. For example, if you are having trouble responding to complaints, we can help you remediate your records and get everything where it needs to be.

We investigate your business, find the cause of problems, and fix them. We can help you write procedures, train staff, and facilitate coaching. Once we leave, your company must be able to sustain medical device regulation compliance on its own, so we make sure your staff has the understanding and skills to do so.

Business Professionals

Corrective Action/Preventative Action

When taking corrective action, a company must go through the following three-step process:

Find the Issue | Assess the Risk to Patients | Contain the Issue

Noyce Quality Consulting LLC helps you find the root cause of the issue using analysis and then eliminates it by implementing corrective action plans. How an issue is contained is based on the risk level to patients. For example, it may be necessary to bring the product back for repairs, or you may be able to leave the product with the patient and simply create a correction within your manufacturing process.

Post-Market Surveillance

Complaints need to go through levels of triage to determine if they are high-risk. We make sure every complaint is researched, recorded, and tracked. Noyce Quality Consulting LLC helps you with FDA reporting of any high-risk complaints. We will teach you how to identify worrying trends as well as how to investigate and rectify them to maintain patient safety and avoid citations.