Medical Device White Papers

	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 regulations.

	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 access global regulatory expertise. This paper will help device companies to identify key outsourcing cost drivers and orchestrate a sound RFP strategy to maximize efficiencies and generate competitive bids.

	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, even when comprised of previously cleared components — devices, delivery systems, compounds or biologics. This paper explores medical combination product strategies to improve the regulatory journey from classification to market clearance for sponsors.

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