FDA 510(k) Consulting

For establishment registration, 510(k) preparation and submission, quality system implementation, and more.

Clients that trust us
Years of experience
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Projects executed
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Offices worldwide

Resolve FDA Compliance Issues with PQE Group's All-in-One 510(k) Consulting

Resolve FDA Compliance Issues with PQE Group’s All-in-One 510(k) Consulting.

Ongoing Support
From Registration To Submission

Ensure FDA compliance and streamline your regulatory process with PQE Group, from establishment registration, 510(k) preparation and submission, quality system implementation, inspection support, design controls, and supplier evaluation, to process validation.

Assistance for establishment registration and device listing for manufacturers and importers.

We prepare forms and dossiers as per device type, ensuring accuracy and compliance with FDA requirements.

We prepare quality documents and procedures to build a robust quality system complying with CFR Part 820.

We offer direct support during FDA inspections, helping implement corrective actions or changes.

We review, determine, and write procedures to control device design, ensuring compliance with requirements.

We audit and evaluate potential suppliers and contractors.

Validation of manufacturing processes with a high degree of assurance when inspections and tests cannot be fully verified by subsequent inspection.

Count On Us For FDA Compliance

Leveraging our insider perspective and over 25 years of expertise, we excel in guiding clients throughout the complex process of 510(k) submissions.

Our thorough understanding of the FDA‘s review process and requirements enables us to oversee our clients’ submissions with unmatched efficacy and attention to detail.

Stephen Tyrpak PQE Group

Stephen Tyrpak

VP of Medical Device Operations US & Canada
Principal Consultant
US Agent for Industry-Leading Companies 

Proven Process, Guaranteed 510(k) Success

Phase 1- Initial Assessment
Phase 1.
Initial Assessment

The initial assessment identifies issues to be solved or support needed.

Phase 2- Risk Analysis
Phase 2.
Risk Analysis

Risk analysis helps us understand project criticality, identify issues, allocate resources, and add value.

Phase 3- Proposal
Phase 3.

The proposal is delivered to the client with details of the service.

Phase 4- Project planning
Phase 4.
Project planning

The right planning is meticulously designed for each specific case.

Phase 5- Gap Assessment
Phase 5.
Gap Assessment

Field experts assess gaps, and deliver a corrective action report.

Phase 6- Implementation
Phase 6.

Remediation actions are implemented per agreed schedule.

Phase 7- Follow-up and support
Phase 7.
Follow-up and support

To ensure effectiveness, the team provides support post-implementation, with periodic reviews if needed.

Phase 8- Project closure
Phase 8.
Project closure

Final report is provided to assess project success.

Our Experts Are Ready To Get You FDA-compliant, Are You?

From strategy to execution, our 510(k) experts are with you to ensure your FDA Compliance.