US-FDA Quality System Regulation * FDA Registration * FDA Compliance * Premarket Notification 510(k) * Medical Device Compliance * Regulatory Insight

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All medical devices distributed in the United States must meet at least some subsections of FDA’s Quality System Regulation (21 CFR Part 820). Most medical devices must comply with most or all of Part 820, including Design Controls.

Regulatory Insight has a full electronic library containing Part 820- and ISO 13485-compliant Quality Manuals, Quality Plans, Quality System Procedures, Quality System Forms, etc. that we customize to each client’s unique organizational and operational needs.

Regulatory Insight prides itself on cost-effectively designing a complete Quality System for your company that is in full compliance with FDA’s Quality System Regulation, as well as the ISO 13485 and CAN/CSA ISO 13485 Standard (if needed) so that you have only one quality system that meets worldwide requirements.

The Quality System we design for your company will specifically fit your company’s exclusive needs based on its size and its applicability to the FDA Regulations (and ISO 13485 Standard) – nothing more.

If you already have a Quality System in place, but are not sure whether it is fully compliant with FDA’s Quality System Regulation, we can review it and identify any gaps before FDA identifies them during an inspection. We can then help you to proactively fill any gaps identified.

Medical Device Compliance

FDA Quality System Regulation
ISO 13485, CAN/CSA ISO 13485
Quality System Audits
Quality System Inspections
FDA-483, FDA Warning Letter,
ISO Assessment Reports
Reportable Events and Recalls

Clinical Studies - Performance Testing

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FDA Registration * FDA Compliance * Premarket Notification 510(k) * ISO 13485 * CE Mark

US-FDA Quality System Regulation * FDA Registration * FDA Compliance * Premarket Notification 510(k) * Medical Device Compliance * Regulatory Insight

Comprehensive worlwide regulatory consulting services.

All medical devices distributed in the United States must meet at least some subsections of FDA’s Quality System Regulation (21 CFR Part 820).
Most medical devices must comply with most or all of Part 820, including Design Controls.

Regulatory Insight has a full electronic library containing Part 820- and ISO 13485-compliant Quality Manuals, Quality Plans, Quality System Procedures,
Quality System Forms, etc. that we customize to each client’s unique organizational and operational needs.

Regulatory Insight prides itself on cost-effectively designing a complete Quality System for your company that is in full compliance with FDA’s Quality System Regulation,
as well as the ISO 13485 and CAN/CSA ISO 13485 Standard (if needed) so that you have only one quality system that meets worldwide requirements.

FDA Registration Consultants * FDA Compliance Consultants * 510(k) Submissions

FDA Registration Consultants | FDA Compliance Consultants | FDA Submissions | FDA Compliance | Medical Device Consulting | Training | Imports/Exports | Contact