MakroCare is ISO 14155 Certified

MakroCare, a drug development and commercialization partner for the pharmaceutical, biotechnology and medical device industries, is now ISO 14155:2011 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. The company’s United States headquarters are in Newark, N.J., but the company has global facilities, most recently opening an office in London, United Kingdom.

MakroCare has medical, regulatory, clinical and quality teams that work to develop and commercialize devices globally. The ISO 14155 certification is a statement of confidence that the company’s processes are standardized at MakroCare to ensure safety, efficacy, performance and quality. Also in possession of ISOs 9001, 27001 and 20000, MakroCare is the only global drug development services firm with this certification combination.

“MakroCare’s achievement of the ISO 14155 certification is testament of its scientific conduct of the clinical investigation and the credibility of the results,” said Laxman Jakkala, Ph.D., head of global quality assurance at at MakroCare.