Early Third-Party Testing Benefits Medical Devices Producers

Source: Today's Medical Developments, Pam Streed  (4/2/12)

"Early engagement of third-party testing partner yields significant benefits to medical device manufacturers."


Today's Medical Developments, Pam Streed

In the already fiercely competitive medical device industry, manufacturers seek the advantage of being the first to incorporate new technology, such as wireless connectivity, into their latest devices. However, manufacturers are also well aware of the delicate balance between ensuring their products represent the quality they promise and staying ahead of the competition.

Creating a high quality product that will meet the medical community’s expectations begins during the product design and development process. Third-party testing partners can be a tremendous resource to manufacturers during these early stages of product design, bringing an external perspective on industry standards that can shed light on opportunities to improve product attributes.

Accepted standards exist to ensure the safe and reliable performance of medical devices. As new technologies emerge, standards will evolve to incorporate these new technologies. There are also numerous areas of crossover among standards; for instance, a medical device that has a light may need to be tested against lighting and medical device standards, whereas a medical device that incorporates wireless technology will have to meet Federal Communications Commission (FCC) requirements in addition to the safety requirements for medical devices. . .View Full Article

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