FDA 510(k) Consulting

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

Experienced 510(k) consultants: Our team includes former agency inspectors and auditors with an insider perspective to ensure 510(k) submission approval.
Global Support: Our diverse team of 50+ nationalities, coupled with our presence in over 45 countries worldwide, ensures our global reach and ongoing support.
Flexibility and Resourcefulness: Our On-site & remote resources are adaptable and tailored to your needs.
Timely Support & Gap Analysis: We offer timely support and gap analysis to ensure successful registration of medical devices.

Clients that trust us

Years of experience

0 +

Projects executed

0 k+

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.

Launch delays due to flawed submissions
Fines for non-compliance
Lack of regulatory knowledge hindering expansion
Customer complaints, Product recalls & Warnings
Challenges in hiring short-term talent & expertise

Error-free submissions for timely launches
Compliance to avoid financial penalties
Expert guidance for regulatory compliance
Enhanced quality control and response
Streamlined talent acquisition for projects

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.

FDA establishment registration

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

Preparation and submission of FDA 510(k)

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

Quality systems implementation

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

Support during inspections

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

Design controls

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

Evaluation of suppliers

We audit and evaluate potential suppliers and contractors.

Process validation

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

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

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

Phase 2.
Risk Analysis

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

Phase 3.
Proposal

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

Phase 4.
Project planning

The right planning is meticulously designed for each specific case.

Phase 5.
Gap Assessment

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

Phase 6.
Implementation

Remediation actions are implemented per agreed schedule.

Phase 7.
Follow-up and support

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

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.

FDA 510(k) Consulting

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