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Medical Device Consulting Services & Solutions
Business & 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.
Medical Device Business Domains
Business domains served in the Medical Device sector include:
Medical Device Consulting Services and Solutions
Medical device consulting services include Business Process and IT consulting, IT Compliance and Computer Systems ValidationMedical 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
