EXPERTISE
Medical Device Post-Market Compliance
Post-Market Compliance Strategy Expertise
Once your medical device goes to market, it doesn’t mean you’re done with compliance. Medical device manufacturers must comply with FDA and international requirements and regulations for devices while on the market and for the lifecycle of the product including traceability and reporting of adverse events.
The following are some of the common post-market compliance situations you may encounter once your device is on the market.
Complaint Handling
A complaint is any expression of dissatisfaction with a product or service that alleges deficiencies in product performance. Complaints can come from any source and all need to be addressed per 21 CFR §820.198 and 21 CFR§ 803 Medical Device Reporting. The complaint system is not to be ignored as each new complaint is potentially an early warning signal that your product could cause a risk to health.
Our consultants can work with you through the proper way to address and trend each complaint, determining what the appropriate internal response should be and ensuring that a Medical Device Report (MDR) is filed if needed. We have experts that have testified on the correct way to handle complaints and identify problems before they get out of hand.
CAPA
A corrective or preventive action (CAPA) is a universal quality tool used to address either existing or potential problems with your products and processes. CAPA’s can be used to resolve both internally or externally generated situations.
We work hand in hand with our clients to analyze systems and identify the root cause of the problem and to ensure a timely solution is identified and effectively implemented.
Audit/Inspection Assistance
Many of our clients have benefitted from a friendly face who is well versed on their specific device, product development history, and Quality Management System during a certification audit or FDA inspection. We arrive on-site and sit alongside your team during audits and inspections to serve as your advocate during the process and help translate to the auditor or inspector how your product and processes satisfy their requests.
In most audits/inspections where we have assisted, our on-site expert has been able to convince the auditor or inspector that at least one of their intended nonconformances was not warranted or should be downgraded to a lower classification, saving the client time and money by avoiding a non-issue. Let our team of experts be your champion during audits and inspections.
Supply Chain Management
Supply chains can make or break a project. Supplier management is critical to many aspects of product design, production verification, packaging and delivery. Supplier-customer relationships and integration of shared goals, with the final user in mind, allows the dynamic process to succeed.
The QA Consulting team is well versed to work with your company and suppliers to create clear supplier agreements that are developed early in the supplier selection process. We can also periodically monitor supplier performance. If you need assistance to select and qualify a supplier or have supplier performance issues, we can help.
FDA 483 or Warning Letter Remediation
At the end of an FDA inspection, your inspector will issue their Form 483 or Notice of Inspectional Observation which lists any issues they found during their audit. Your timely response to the identified issues will be reviewed internally by the agency and could escalate into the issuance of a Warning Letter if the issues were far too critical or your response is deemed inadequate.
Few quality systems are perfect and it is not uncommon to find yourself with at least one Form 483 observation after an inspection. Remediation should begin the day you receive your Form 483 or Warning Letter as most require 15 days to respond. Our team has worked with former FDA inspectors to develop a response and remediation method which has been well-received and resulted in close-out of the observations without a Warning Letter.
