Medical device consulting services
Three ways we work with device companies. Design assurance is where GSD adds the most value: in the project, executing the work. Quality system development gives that work a system to live in, and auditing is the independent check that both are working.
Design Assurance
For device development and manufacturing teams, from first prototype through launch and beyond
Hands-on execution of design controls inside your project team: design inputs, risk management, usability, V&V, design transfer, clinical studies and the submission, built as one evidence story while the device is being built.
Three pathways: Ideation to Device Realization · Design to Human Use and Commercialization · Post-Production Support
Quality System Development
For start-ups, contract manufacturers and established companies remediating or transitioning
ISO 13485 systems built, rebuilt or right-sized, with FDA QMSR, EU MDR and MDSAP mapped onto one set of procedures your team can run.
Quality System Auditing
For manufacturers, supplier quality teams, and investors doing diligence
Independent internal audits, supplier audits and mock inspections by a certified biomedical and medical device auditor who audits the way regulators do.
ACROSS THE PRODUCT LIFECYCLE
Full range of services
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Quality Management – Design Assurance, Quality Systems, Operations Quality
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Regulatory Affairs Management – FDA Submissions, Notified Body Management
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Quality System Development – ISO 13485, 21 CFR 820
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Product Development/Design Controls – Project Management, Quality Engineering
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Risk Management – ISO 14971
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Operations Management – DMR development, EH&S
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Clinical study management – ISO 14155
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Internal Auditing