Medical Device Consulting Services & SolutionsBusiness & Decision provide specialist consulting services and solutions within the entire medical device value chain, for organizations involved with the design, development, manufacture and sale of all classes of medical device. Business domains served in the Medical Device sector (see top left) include:
Medical Device Consulting Services and SolutionsMedical device consulting services include Business Process and IT consulting, IT Compliance and Computer Systems Validation. Medical device solutions include Systems Integration of sector specific solutions, compliant hosting, managed services and training. Services meet international regulatory expectations in the medical device and pharmacotherapeutic sector (see also Pharmaceuticals) and business solutions assure appropriate regulatory compliance with relevant Quality Systems Regulations (GMP). Services and solutions are delivered in accordance with applicable regulations such as 21CFR Part 820 and ISO 13485, but are also scaled according to device class where quality standards such ISO 9001 are applicable. |
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