REGULATORY  (Best Path to Approval)

REGULATORY (Best Path to Approval)

Regulatory strategy, FDA Pre-sub, clinical trials, submission & review. FDA (510(k), de novo, PMA), CE (MDD/MDR, IVDD/IVDR), Health Canada.

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QUALITY SYSTEMS   (Ready for an Audit)

QUALITY SYSTEMS (Ready for an Audit)

QMS implementation, audit and certification support. In addition, help with FDA warning letters and acquisition QMS due diligence.

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TRAINING  (Customer Live Quickly)

TRAINING (Customer Live Quickly)

Live-video and phone training by skilled training professional for labs implementing Point-of-Care/Near-Patient analyzers and tests.

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