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Recent Posts
Medical device organizations face a number of regulatory and compliance challenges ranging from design and development...
With the American Medical Device Summit 2016 right around the corner we wanted to take some time to sit down with...
Medical device developers face an array of regulatory, compliance, quality and risk challenges. Throughout the past...
In our previous posts we have looked into some of the challenges that documentation can present during a medical...
The American Medical Device Summit is less than one month away! The summit will draw on the knowledge of over 40...
Medical device developers are evolving and introducing new products and variants into the market. With this evolution...
Wearable devices have become a commodity; devices act as fitness and health trackers, work and lifestyle guides as well...
In August 2015 the FDA’s Center for Devices and Radiological Health (CDRH) implemented a requirement for manufacturers...
Quality control and regulatory compliance are paramount in medical device development. A fully validated tool can help...
The evolving regulatory landscape and the accelerated pace of medical device innovation are increasing pressure on...