Regulatory Assist

Our Services

Specialized consulting to help you navigate the complex landscape of medical device regulations.

ISO 14971 Risk Management

ISO 14971 Risk Management

Complete Risk Management Files (RMF) including plans, hazard analysis, FMEAs, and reports that pass audits.

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ISO 13485 QMS

ISO 13485 QMS

Gap assessments, SOP development, internal audits, and CAPA management to ensure full compliance.

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FDA 510(k) Submissions

FDA 510(k) Submissions

Strategic predicate selection, testing plans, and eSTAR preparation for successful FDA clearance.

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EU MDR Transition
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EU MDR & CE Marking

Transition to MDR, GSPR compliance, Clinical Evaluation Reports (CERs), and Post-Market Surveillance.

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