Specializing in Quality Assurance and Regulatory Affairs consulting for
medical device and in-vitro diagnostics manufacturers.
After 20 years working in Quality Assurance and Regulatory Affairs for medical device and IVD companies, I decided to alter direction. I've opened myself up to other companies in the industry who need assistance in premarket strategy and post-market compliance.
Need help preparing for an audit or remediating audit findings? Wondering how your company will be affected by the new EU MDR and IVDR regulations? Having trouble with a registration? Past clients range from startups to corporations. No job is too big or too small.
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