Learn More About Our Medical Device Expertise
For your convenience, our white papers, overviews and fact sheets can be accessed here.
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
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
While heart disease is the leading cause of death worldwide, thankfully significant advances in technology-based treatments for cardiovascular disease have been made in recent years. Sponsors seeking to bring implantable cardiovascular products to market face several significant factors in designing … Read More
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
The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) issued draft guidances to revise its 510(k) premarket notification process for medical devices. The revisions aim to bring efficiencies and predictability to the approval … Read More