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 product’s lifecycle, including traceability and reporting of adverse events.
We can help you plan for and navigate post-market compliance situations you may encounter once your device is on the market.
How reliable is your device in the real world?
Post-market surveillance (PMS) actively monitors medical devices for safety and efficacy once they reach the market. Depending on the device (and region), regulatory agencies require manufacturers to establish and maintain PMS programs. PMS involves developing a risk-mitigating action plan, data collection, data evaluation, root-cause analyses, and corrective actions (as needed).
QA Consulting consultants are experts in regulatory compliance and quality assurance — including post-market surveillance — and we’re here to help medical device manufacturers get and keep their devices on the market.
A complaint is any expression of dissatisfaction with a product or service alleging product performance deficiencies. Complaints can come from any source, and devices sold in the US must address them per 21 CFR §820.198 complaint files and 21 CFR§ 803 Medical Device Reporting. The complaint system deserves close attention as each new complaint is potentially an early warning signal that your product could cause a health risk.
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) gets filed if needed. By leaning into our expertise, you can handle complaints and identify problems before they get out of hand.
A corrective and preventive action (CAPA) is a universal quality tool used to address either existing or potential problems with your products and processes. CAPAs resolve both internally and externally generated situations.
We work hand in hand with our clients to analyze systems, identify the root cause of the problem, and ensure a timely solution is identified and effectively implemented.
“I want to thank you a lot for your help throughout this process. With your guidance and expertise, you really pointed us toward the best path to be successful, and I am extremely grateful for that. I hope that this was just the first of many projects that we have with QA Consulting.”
– Darren DeMerritt, Director of RA/QA, ReNu Medical
Are you in need of a CAPA partner?
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 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 successfully saved the client time and money by explaining to the auditor or inspector how the clients’ system does meet the requirements such that at least one of their intended nonconformances was not warranted or should be downgraded to a lower classification. 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 product design, production verification, packaging, and delivery. Supplier-customer relationships and integration of shared goals, with the final user in mind, allow the dynamic process to succeed.
The QA Consulting team is well-versed to work with your company and suppliers to create clear supplier agreements developed early in the supplier selection process. We can also periodically monitor supplier performance. If you need assistance selecting and qualifying a supplier or have supplier performance issues, we can help.
FDA 483 or Warning Letter Remediation
Few quality systems are perfect, and finding yourself with at least one Form 483 observation after an inspection is common. At the end of an FDA inspection, your inspector will issue their Form 483 or Inspectional Observation which lists any issues they found during their audit. The key is to prevent them from escalating into a Warning Letter due to the issues being too critical or responses deemed inadequate or untimely.
Our team is familiar with working with FDA inspectors to develop a well-received response and remediation method. With our expertise and history of successfully closing out observations without a Warning Letter, you can easily prevent escalation and make it through FDA 483s.
Medical Device Post-Market Compliance with QA Consulting
QA Consulting is here to help you plan, navigate, and implement all aspects of medical device post-market compliance. By leveraging the experience of an expert, the process becomes thorough, painless, and risk-reduced.
As an extension of your team, we can create customized solutions that help you deploy regulatory and quality affairs strategies that will achieve your business goals.
Are you ready to streamline your post-market compliance activities?