´╗┐Medical Device White Papers

Best Practices for Interventional Cardiovascular Medical Device Trials
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 and conducting clinical trials; our paper addresses the four factors we consider most critical: regulatory requirements, reimbursement strategies, clinical challenges and vendor selection.
510(k) Reform and the Resulting Impact on Medical Device Developers
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 process while ensuring device efficacy and safety. This paper reviews 510(k) reform implications for sponsors, with a focus on four key draft guidances. 
Download 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.
Download 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.
Download 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.


Certified QualityCertified Quality

We don't just say quality... we prove it.