Max Neeman International ISO 14155: 2011 Certified for Medical Device Trials
RESEARCH TRIANGLE PARK, N.C., Sept. 28, 2011 /PRNewswire/ -- Max Neeman announces the grant of ISO 14155:2011 certificate; the only Indian CRO and one of only a few global CROs to be certified for design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
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Max Neeman has formed an experienced team of medical device experts specializing in carrying out Cardiac, CNS, Ophthalmology and various other device therapeutic trials and ISO 14155 certification establishes standards to harmonize these trials ensuring safety, effectiveness, performance and quality. The company is part of the 'Max India Group' also consisting of Max Healthcare, which owns and manages a leading cardiovascular institute among its 13 hospitals.
The ISO 14155:2011 certification Max Neeman has achieved, specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
With India's device market currently being valued at US $1.7 Billion and projected to grow at the rate of 23% annually, India is fast emerging as a destination of choice for medical device development and conducting device trials.
About Max Neeman International
Max Neeman International is one of the leading and largest CROs in India. Our specialty is that we offer services for the successful conduct of Phase II-IV clinical and device trials for small and mid-sized international and national Pharmaceutical, Biotechnology, Medical Device and Nutraceutical companies in compliance with ICH GCP standards. Operational since 2001, Max Neeman is also an ISO 9001:2008 & ISO 27001:2005 certified CRO for Monitoring, Site Management and Data Management Services. The company is presently active in 31 cities with 6 regional offices. Contact Donald Swankie, Vice President USA for more information at +1.919.424.3345 / donald.swankie@neeman-medical.com.
SOURCE Max Neeman International