Medical and Regulatory Affairs

Premier Research Expands Certification Under ISO Standard for Medical Device and Diagnostics


On Monday, June 30, 2014, Premier Research expanded its ISO certification as a provider of strategic and regulatory consulting, clinical development, and post-marketing surveillance services to manufacturers of medical devices and diagnostics. This certification includes ISO 9001:2008 and aspects of ISO 13485:2003, the key quality management standards required by international regulatory authorities and—therefore—by Premier’s customers.

Premier Research has extended its ISO certification across two more of the company’s key sites, Philadelphia in the US and Wokingham in the UK. The Yverdon-les-Bains site in Switzerland has been certified to ISO 9001 since 1999 and ISO 13485 since 2008.

“The expansion of ISO certification to our global operations confirms our company’s commitment to quality by design,” said Kimberly Hunsicker, Vice President, Medical Device and Diagnostics. “It is within the fundamental ISO framework that management, starting at the top, rigorously and continually reviews every aspect of quality and ensures customers an unparalleled level of dependability and customer service.”

ISO 9001 and 13485 outline a quality management system that demonstrates an organization’s ability to provide key services that consistently meet customer needs and regulatory requirements. ISO, the International Organization for Standardization, is the world’s largest developer and publisher of international standards.

About Premier Research
Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs with a special focus on addressing unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 50 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.