PRODUCT TESTING FOR THE MEDICAL INDUSTRY
When your business involves the manufacturing of equipment designed to promote the health of patients, you have zero room for faults and weaknesses in your devices. Also, you need to be sure your products meet or exceed all standards set by the FDA, FCC and ANSI — as well as any other regulations put in place by the organizations who will eventually be counting on your products to work successfully.
In all these cases, the best way to root out faults in design and materials before any medical product goes into use is through robust testing from a qualified testing lab. Unfortunately, working with large testing labs often requires navigating challenging amounts of red tape, then having to wait extended periods for results.
The alternative is to work with a testing lab like Quality Testing Services, LLC. For more than two decades, we’ve been providing each of our clients with personalized attention and fast, reliable testing results. From testing pacemakers for the medical industry to ensuring the quality of mission-critical devices used in a host of lifesaving and first responder situations, QTS helps take the risk out of going to market with your medical device in a unique manner that saves you time, money and hassle.
HALT Testing for Medical Industry
When it comes to Accelerated Stress Testing (AST), the medical industry is quickly discovering that HALT — Highly Accelerated Life Testing — can help uncover more than 30 percent of design weaknesses and failures that traditional tests would miss. Plus, because of its very nature to put workpieces under incrementally increasing stresses until failure occurs, HALT discovers the design limitations of a product in hours rather than the days and weeks that other forms of testing take.
Clearly, for medical device manufacturers who are under increasing pressure to bring fault-free products to market sooner, HALT testing provides significant benefits that other tests cannot match. The result is a better product in less time. This means manufacturers can take the necessary time during the design phase to get it right, instead of waiting to find out during manufacturing — or worse, once on the market and in use — that a product needs to be recalled.
HASS Testing for Medical Industry
According to the FDA’s criticality classifications, class I through III medical devices are recommended to be both HALT- and Highly Accelerated Stress Screening (HASS)-tested by a qualified lab like QTS — especially those that rely on electronic assemblies for their operation.
With both patient expectations and medical device lifecycles increasing, the added security of HASS testing is a must for manufacturers who want to limit the risks associated with upstream suppliers and the manufacturing process. By replicating incrementally increasing thermal and vibration stresses that exceed a product’s specifications but remain within earlier HALT parameters, HASS testing uncovers weaknesses and flaws during the all-important stages of production and manufacture.
QTS for Superior Medical Device Testing
Without a testing facility you can trust, every one of your medical devices is more prone to warranty issues, and your entire product line is susceptible to recall. Adverse impacts to your profitability, brand and overall company are what’s on the line.
This is why since the former head of the HALT/HASS testing labs at Qualmark established Quality Testing Services, we’ve steadily built our reputation as a testing lab that clients can count on for superior service, guidance and value.
To learn more about our medical device testing services or request a quote, contact us today. Our team is here for you.