Safety Critical Systems

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The CRO Group works with and has worked with a variety of safety critical system developers and manufacturers to assist in FDA and EU submissions, establish and maintain Quality Systems, auditing and training. Some of the systems we have been involved in include:

– Diagnostic Imaging such as PET Scanners

– Cell Washing systems

– Rare allele diagnostic assay systems

– Robotic Systems including Orthopedic Implant Surgical and Physical Therapy Exercisers

For each of the above systems, The CRO Group excels in ensuring that all the safety critical “bases” are covered including:

– Risk Management
– Functional Safety
– Usability
– Labeling Validation
– System and Software Verification and Validation
– Design Documentation for FDA, EU, and other country and regional regulations