For establishment registration, 510(k) preparation and submission, quality system implementation, and more.
Resolve FDA Compliance Issues with PQE Group’s All-in-One 510(k) Consulting.
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.
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
VP of Medical Device Operations US & Canada
Principal Consultant
US Agent for Industry-Leading Companies
The initial assessment identifies issues to be solved or support needed.
Risk analysis helps us understand project criticality, identify issues, allocate resources, and add value.
The proposal is delivered to the client with details of the service.
The right planning is meticulously designed for each specific case.
Field experts assess gaps, and deliver a corrective action report.
Remediation actions are implemented per agreed schedule.
To ensure effectiveness, the team provides support post-implementation, with periodic reviews if needed.
Final report is provided to assess project success.
From strategy to execution, our 510(k) experts are with you to ensure your FDA Compliance.
ISO 9001 Certified compliance services provider since 1998.
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