Client success story
Medical Device Quality Systems
Business Value: Streamlining Regulatory Submissions and Reducing Compliance Risks
Summary: Ensuring Efficient Quality Systems for Medical Devices
bPrescient works with several medical device manufacturers to develop and review their design controls and quality systems for development of software components of medical devices. Our consultants provide guidance on requirements documentation, testing, and review processes. These procedures enable clients to efficiently and accurately prepare medical devices for regulatory submissions.
Challenge: Increasing Complexity in Diagnostic Device Development
Diagnostic companies require robust quality documentation to ensure their devices work as designed and for gaining regulatory approval. Quality systems are complex to set up and require regular review to comply with FDA and international regulations. As diagnostic devices become more complex and analyze complex input data such as imaging or DNA sequences, the risk of software failure increases.
Solution: bPrescient Experts Implement Robust Design Controls and Documentation
bPrescient consultants set up design controls and quality systems, providing advice on strategy and tool selection, document templates, review processes, and traceability. Our analysts are skilled in developing product and software requirements based on stakeholder input, and in reviewing those requirements to ensure accuracy and completeness.
Outcome: Improved Accuracy in Device Testing Leads to Regulatory Success
Our clients develop, document, and test their medical devices based on procedures and evidence recorded in their quality systems, and assemble documents efficiently and accurately for regulatory submissions.
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