The product surveillance system is a major element of the company’s quality system and needs to be “bullet proof” in that it is usually the starting point for regulatory audits. This system needs to be particularly sensitive to product performance in the field not only for regulatory and product liability purposes but for competitive purposes as well.
Many companies don’t really know what constitutes a complaint and therefore wind up with serious regulatory problems related to under-reporting MDR, inaccurate trending and lack of CAPA.
Complaint handling and medical device reporting are two areas associated with the regulatory affairs function but given today’s market and FDA regulatory posture, these two functions are critical to the manufacturer in terms of product liability and regulatory actions including recall.
Given the nature of these required functions, other areas within the organization such as manufacturing, quality systems, sales and service must be integrated.
DBT can help with these tasks with the following services:
- Design/Review Complaint Handling Systems, Adverse and Medical Device Reporting systems.
- Help define what complaints are and are not.
- Update or install MDR systems in compliance to the MDR regulations.
- Design/Review Failure investigation methods and documentation.
- Integration into a CAPA system