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About The CRO Group:Welcome to our new website. We are not just "another CRO." In our case, CRO stands for "Contract Regulatory Organization." Our specialties include cost effective CE Marking and Quality System / ISO 9000 certification programs, and FDA QSr (Quality System regulation) compliance programs, including the new Design Control Requirements. We also prepare 510(k) submissions, technical files, PMAs, design dossiers, and IDEs. With partners and consultants in the USA, Canada and Europe, The CRO Group is uniquely qualified to handle virtually all your regulatory compliance and market access issues. Each partner and affiliate is qualified to handle general medical device and quality system issues such as labelling, risk analysis, and design and process validations. Then, for subspecialties such as clinical investigations, sterilization validations, dielectric withstand, or waste disposal, we rely on our partners and affiliates robust backgrounds with medical and pharmaceutical product manufacturers. And by the way, we also provide "CRO" - contract research organization - related services for our clients, including clinical study design, protocol development, IRB/IEC approval submissions, clinical trial management and auditing, and preparation of reports to support submissions. |
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