Learn More About Our Medical Device Expertise

For your convenience, our white papers, overviews and fact sheets can be accessed here.


Clarifying the Regulatory Road for Combination Products

The shifting borders among traditional drugs, biologics and medical devices are poised to produce safer and more effective combination products that offer new diagnostic and treatment options for patients. But such novel combination products pose numerous regulatory hurdles for sponsors, … Read More

Medical Device Development: A Pathway to Harmonization

The global medical device industry is facing strengthening competition, rapid technological innovation and increasing regulatory scrutiny while growing at an impressive rate. This paper provides an overview of the current premarket device development arena and global harmonization of medical device … Read More

Best Practices in Outsourcing Medical Device Clinical Trials

Both large and small medical device companies are outsourcing clinical trials at an increasing rate. Utilizing external resources can be attractive to device manufacturers due to both the financial and operational flexibility of various outsourcing models and the ability to … Read More