Verification of Medical Devices in Remediation
1. Introduction
We know the importance of verification of medical devices before they are used on patients. It is essential to verify if the device meets the user needs and its intended use, ensure deficiencies are discovered and corrected prior to the release of the product. But what is the role of verification of medical devices in remediation?
What is verification of medical devices in Remediation? Why is it important?
Design history files (DHFs) are a corpus of documents that describe the design history of a finalized product, including verification. This is required by the FDA (Food and Drug Administration) as part of the design controls (21 CFR Part 820.30), within the main quality system. An entrenched design control process will ensure that the DHF contains all the verification records required by the regulatory agencies for various geographical regions. As the medical device regulatory requirements change and as you update your quality system, it is cardinal to ensure that the verification records are compliant with the new standards. This process of making the verification records for medical devices compliant with the new standards is termed as verification in remediation.
Client Scenario
Our client is a leading manufacturer, that offers medical devices and its accessories, software, services for diagnosis, monitoring and treatment of impairments and disorders affecting newborns, neurology, nerves, balance, and hearing. Their medical devices are used in hospitals, medical clinics, and laboratories across the globe. Client wanted to remediate some of their medical devices. Thus, it became imperative to verify if the product met the regulatory requirements explicitly stated in U.S Regulations, ISO Standards, MDR-European Markets and CFDA-China. Thorough documentation along with actual verification of the medical devices was essential to be done which needed expertise in handling the medical devices and having in-depth knowledge of the software associated with them.
2. Solution Implemented
Decos offered remediation services to update and create the verification related documents to maintain the devices throughout their lifecycle.
This included the identification of differences in the existing technical documentation followed by the creation or update of the documents to comply with applicable standards and regulations.
Our profound understanding from being in business for a long time eased the process of analysing the product requirements, creating a verification plan, verification protocols, performing actual verification on the medical devices, creating verification records, highlighting defects in the product, creating defect summary reports as well as verification summary reports and traceability matrices.
We worked to ensure all design history verification files for existing products were accurate, up to standard and ready for the next audit by getting them implemented in Agile PLM – an application used for reviewing and approving Quality Management System and other business documentation prior to the distribution to the point of use.
3. Benefits Derived
Some of the key benefits of this verification of the medical devices project, were
1. Created and updated of the following quality documents crucial for remediation:
- Verification Plan
- Verification Protocols
- Verification Records
- Traceability Matrices
- Defect Summary Report
- Verification Summary Report
2. Ensured that the medical devices met the intended use and were safe to be used on real patients by conducting thorough system testing, regression testing and re-testing on them.
3. Helped the client prepare for further audits and facilitate the sale of products in the market by maintaining and releasing all the documents in the Agile PLM.
Contact our team today for expert Verification and Remediation services, ensuring regulatory adherence and market success.
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