Effective planning helps you get success in the medical device manufacturing industry. Unfortunately, the industry has seen many high-profile medical regulatory compliance issues. Luckily, looking at their mistakes, you can learn to have better medical device and equipment compliance.
In this article, we are listing the four most common medical regulatory compliance issues. These issues create a pitfall causing irrevocable damage to your customers and leave you vulnerable to regulatory compliance problems.
1. CAPA (Corrective and Preventive Action)
CAPA is the most commonly cited issue for medical device development non-compliance. Most companies get caught up in the burden of CAPA and often overuse or go the other extreme by ignoring a much warranted CAPA issue.
However noteworthy, establishing CAPA procedure early with all other elements and components of a quality management system is the best solution. You are wrong to think that you will focus on CAPA only when a problem arises. It is best to have the quality management system designed to address quality issues.
Since not establishing and documenting the CAPA procedures properly are very common, FDA considers it very strictly. The smallest non-compliance can lead to rejection.
Thus, treating the components of a quality management system as important and prioritizing those helps you abide to the medical device compliances.
2. Complaint Procedures
Another common non-compliance issue is an adequate complaint management system. Your complaint management system must be compliant with the procedure outlined in 21 CFR 820.198.
You won’t need it during designing and building your device. However, once you roll out your product into the market, you need to ensure having a robust complaint management system.
The centralized quality management system must be capable of handling complaints promptly. The nature of the complaint, actions taken, and effectiveness of the resolution provided must be noted in a well-ordered system to be sorted and filtered easily at any point in the future.
3. Creating Closed-Loop CAPA Processes (from design to manufacturing)
You need to establish CAPA processes as outlined in 21 CFR 820.100. CAPA processes consist of several steps involving doing analysis, identifying the issues, and finding the solution.
Close-looping the CAPA process implies noting a rectification done and suggesting preventative measures have been put in place to avoid similar issues in the future. To do so, you need a proper quality management system and connect it to CAPA processes and product records.
A product-centric QMS solution with records of all parts, assemblies, and documents helps you directly connect quality and CAPA processes. This product-centric QMS solution also provides better control and traceability for quick resolution of the problems.
4. Process Validation Hangups
Yet another common issue is obstacles in process validation. It is difficult for organizations and FDA to test every single drug and equipment. And so, they check the quality management system. Their outlook is that if your processes are thoroughly validated, the results will possess the same consistency and quality throughout the production batch.
Know more about Medical Device Regulatory Compliance Issues
These four issues are among several common problems faced by medical device manufacturers. You can check our webinars to get relevant in-depth knowledge on this subject and other subjects related to medical devices. We offer webinars, seminars and certification at nominal pocket-friendly costs to help you navigate the complex regulatory landscape.