In the world of medical device testing, manufacturers should seek to identify key characteristics that set a high-quality laboratory aside from the rest. A successful medical device testing relationship should be built on trust, quality, and integrity. Some potential consequences for choosing an incapable third-party testing partner include inaccurate results, legal liability, regulatory compliance issues, wasted resources, and more. Most importantly, failure to achieve FDA approval or regulatory approval can lead to timely delays, wasted products, and the loss of business opportunities.
How to identify a medical device testing partner
While the cost of medical device testing is often a determining factor, it’s essential to consider the cost of quality when selecting a testing partner. Additionally, assessing the laboratory’s ability to deliver testing results within required timelines without compromising quality is an advantage. It is critical not to be misled into unrealistic turnaround times or lower costs that could lead to re-testing and/or delays due to unreliable data driven by a lack of competence in testing. High-quality reliable data you can trust comes with appropriate timelines required to support critical sample preparation, strict quality control measures, and complex analysis.
In addition to cost and turnaround time, be sure to look for the following criteria when choosing a medical device testing laboratory to support your products:
A strong quality system
Quality management systems (QMS) are essential to ensure the reliability of all aspects of testing. From safeguarding the accuracy and confidence of results to the implementation of quality control measures, a strong QMS contributes to greater trust in 3rd party testing. One that has been regularly audited by the FDA is favorable.
Actively participates in standard development
Continued involvement at industry meetings including standard development keeps testing laboratories at the forefront of regulatory science and enables them to help you make the right testing decisions that are compliant and widely accepted. Technical expertise and experience go a long way in the proper support and understanding of the ever-evolving world of standards.
Upholds proper accreditation (ISO 17025)
The first sign of technical competence is accreditation to ISO 17025 which specifies the general requirements to carry out tests and/or calibrations, including sampling. Compliance with the FDA’s ASCA program is also desirable in addition to other industry-specific organizations. Accreditation demonstrates 3rd party testing compliance with international standards and ensures the credibility of lab testing services.
Robust regulatory resources
Internal subject matter experts who understand the complexities of globally regulated manufacturers will lead to more successful testing outcomes. Selecting a third-party laboratory that offers in-house expertise in this area can help reduce the regulatory feedback burden.
Customer-driven
Reliable and accurate medical device testing results are essential for maintaining customer satisfaction. Since a test report is often the final product provided by a testing laboratory, the overall customer success should be highlighted as critical to the overall success of the laboratory.
By specifically evaluating these factors, you can identify a strong third party testing partner that meets your specific testing needs and standards of quality, reliability, and competence.
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