To bolster its position further in Medical Device segment, MakroCare 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.
MakroCare has experienced medical, regulatory, clinical and quality teams who bring in all facets of expertise needed to develop and commercialize devices globally. With this ISO 14155 certification, it’s proven that processes are standardized at MakroCare to ensure safety, efficacy, performance and quality. Along with this and other certifications (ISO 9001, 27001, 20000), MakroCare achieved a rare feat of being the only global drug development services firm with these certifications combination.
“MakroCare’s achievement of the ISO 14155 certification is testament of it’s scientific conduct of the clinical investigation and the credibility of the results” mentioned Dr.Jakkala, global quality management representative for this ISO certification”.
MakroCare has 5 main divisions – Consulting, CRO, SMO, DDi, and Commercialization. Through these focused divisions, it offers project management, regulatory affairs, risk management, site selection, patient recruitment, trial management (P II/III and late phase), clinical monitoring, biometrics, safety/pv, informatics (eClinical products, solutions), medical affairs, bpo and call center services. MakroCare delivers service from offices in USA, UK, Europe and Asia.