Medical technology and innovation are booming like never before. The unforeseen outbreak of COVID-19 has slowed breakthrough progress in the medical device industry, but even amid the pandemic, the rise of breakthrough devices has continued to revolutionize the delivery of care. Today, medical device manufacturers and healthcare service providers find themselves in a difficult situation due to the emergence of complex regulatory requirements and ever-changing customer needs. They face the challenge of bringing new and improved products to market while adhering to the highest quality standards and regulations, resulting in the need for testing and certification partners who can reliably ensure product compliance. products and speed up time to market.
As one of the trendiest medical devices, wearables undergo a plethora of tests such as electromagnetic compatibility (EMC) or specific absorption rate before being checked and validated for use. Manufacturers must also ensure that their wearable devices meet strict safety, quality and performance standards set by regulatory bodies. Another key aspect that is gaining importance in today’s medical device market is packaging. Companies working on medical device packaging must ensure that products have accurate labeling that displays their usage information. For consumer devices, packagers must pass a series of FDA-mandated certifications and tests to ensure compliant and effective protection against environmental variables.
In this edition of MedTech Outlook, we profile some of the most promising medical device testing and certification companies. The edition features thought leadership articles from Myriam Curet, executive vice president and chief medical officer at Intuitive, Joe Kimura, chief medical officer at Atrius Health, and Mike VanDerwerken, director of pharmacy at Saratoga Hospital. The edition also features innovative testing service providers, including WCG Imaging, which offers comprehensive services to support Phase I-IV clinical trials and Class I, II, III medical device trials.