DESIGN ASSURANCE · QUALITY SYSTEMS · REGULATORY AFFAIRS · AUDITING
Partnership that takes your medical device over the finish line.
GSD Medical Device Consulting works to supplement your team where and how you need us. Quality System development, Design Assurance, Regulatory Affairs - as much or as little as your current needs require. Scalable with your company and your project plan.
We can improve or work within your existing Quality Management System, or we can implement a system that is staged to the state of the product so it supports the work instead of slowing it.
We can work with your design and manufacturing team, executing design controls, risk management and verification alongside your engineers.
We can provide FDA regulatory support from strategy through post-market, led by RAC-credentialed consultants.
Safe. Effective. Available. By design.
SERVICES
Four ways we work with device companies.
Design Assurance
Hands-on execution of design controls alongside your project team, from first prototype through launch. Where and when you need us.
Quality System Development
ISO 13485 systems built, rebuilt or right-sized, with QMSR, EU MDR and MDSAP mapped onto one set of procedures.
Quality System Auditing
Internal audits, supplier audits and mock inspections by a certified auditor who audits the way regulators do.
Regulatory Affairs Consulting
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FDA regulatory support from strategy through post-market, led by RAC-credentialed consultants who have taken products from first-in-man through 510(k) and PMA.
OUR APPROACH
Three outcomes every engagement works toward.
SAFETY Device is designed to minimize patient risk.
EFFICACY Performs as claimed, every unit, for its whole life.
AVAILABILITY Get your device into the physician's hands as quickly as possible.
WHY GSD
Fifty-plus years on the manufacturer's side of the table.
Preparing for an FDA inspection, a Notified Body audit, or a design review?
Let's talk through where your device and quality system stand.