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FDA Regulatory Consulting for Medical Devices

MEDICAL DEVICES

Provision Consulting Group provides FDA regulatory consulting for medical devices, from product classification and submission strategy to U.S. market entry and ongoing compliance.

Our services include FDA Pre-Submissions, 510(k), De Novo and PMA submission support, quality management systems under 21 CFR Part 820, establishment registration, device listing, U.S. agent services, and Initial Importer support.

We also provide testing and clinical planning, label review and claims support, on-site inspections, warning letter and inspection responses, regulatory training, and FDA regulatory liaison.

Advisory is highly recommended for both early planning and continued compliance guidance. Real-Time FDA provides on-demand regulatory support on your behalf when Customs or FDA flags a product for non-compliance or suspected non-compliance during U.S. border entry.

medical devices

Medical Device FDA Regulatory Services

  • Product classification and product code

  • FDA Pre-Submission planning and preparation

  • 510(k), De Novo, and PMA submission preparation and critical review

  • Testing and clinical study planning

  • Quality management systems — 21 CFR Part 820 (QMSR)

  • Label review and claims support

  • FDA establishment registration and device listing

  • U.S. agent services

  • Initial Importer services

  • On-site inspection

  • Warning letter and inspection responses

  • Regulatory training

  • FDA regulatory liaison

  • Advisory and ongoing compliance guidance

  • Real-Time FDA support during customs

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