PQE Group
★★★★★
3.8
/ 5
•
31 reviews
FDA 510(k) Regulatory and Quality Consulting Firm - 12 Years Experience
PQE Group is a dedicated regulatory and quality consulting firm with 12 years of experience specializing in FDA 510(k) submissions. They offer comprehensive, all-in-one solutions to help medical device companies successfully navigate FDA regulatory pathways and achieve 510(k) clearances. PQE Group serves clients globally, including in the US and EU, ensuring a thorough approach to regulatory compliance.
About
**Who they are**
PQE Group is a regulatory and quality consulting firm with over 12 years of experience, specializing in the Life Science sector. They have completed over 15,000 projects since 1998, collaborating with major global companies in the Pharmaceutical, Medical Device, and Biotech industries.
**Expertise & scope**
* Regulatory Affairs Consulting, including FDA 510(k) preparation and submission, establishment registration, and process validation.
* Quality Compliance and Management Systems, including ISO 9001 certification.
* Data Integrity and Digital Governance solutions.
* Commissioning, Qualification, and Validation (CQV).
* Laboratory Excellence and Engineering services.
* Support for EU Market Entry and CE Marking for Medical Devices.
* Expertise in the new FDA Quality Management System Regulation (QMSR) and its alignment with ISO 13485:2016.
**Reputation / proof points**
* Over 15,000 completed projects since 1998.
* ISO 9001 certified.
* Experience with Pharmaceutical, Medical Device, and Biotech sectors.
PQE Group is a regulatory and quality consulting firm with over 12 years of experience, specializing in the Life Science sector. They have completed over 15,000 projects since 1998, collaborating with major global companies in the Pharmaceutical, Medical Device, and Biotech industries.
**Expertise & scope**
* Regulatory Affairs Consulting, including FDA 510(k) preparation and submission, establishment registration, and process validation.
* Quality Compliance and Management Systems, including ISO 9001 certification.
* Data Integrity and Digital Governance solutions.
* Commissioning, Qualification, and Validation (CQV).
* Laboratory Excellence and Engineering services.
* Support for EU Market Entry and CE Marking for Medical Devices.
* Expertise in the new FDA Quality Management System Regulation (QMSR) and its alignment with ISO 13485:2016.
**Reputation / proof points**
* Over 15,000 completed projects since 1998.
* ISO 9001 certified.
* Experience with Pharmaceutical, Medical Device, and Biotech sectors.
Additional information
PQE Group offers comprehensive support for navigating complex regulatory landscapes, particularly for medical devices and pharmaceuticals. Their services are designed to help clients achieve compliance and turn it into a competitive advantage. They emphasize scalable, cost-effective, and regulatory-ready solutions, including AI-enabled approaches. Clients can engage with PQE Group through various channels, including a contact form, and can expect support for both ongoing activities and corporate growth initiatives. Their global presence, with locations in Europe, allows for local support with a global perspective.
Key Highlights
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PQE Group has over 12 years of experience in FDA 510(k) regulatory and quality consulting.
Source
“FDA 510(k) Regulatory and Quality Consulting Firm - 12 Years Experience”
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They provide comprehensive Regulatory Affairs support, including 510(k) preparation and submission.
Source
“From establishment registration, 510(k) preparation and submission, quality system implementation, inspection support, design controls, and supplier evaluation, to process validation.”
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PQE Group offers expertise on the new FDA Quality Management System Regulation (QMSR) and its alignment with ISO 13485:2016.
Source
“The FDA’s new Quality Management System Regulation (QMSR), taking effect in February 2026, represents the most significant shift in U.S. medical device quality requirements in decades.”
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The firm has a history of over 15,000 completed projects since 1998.
Source
“More than 15k completed projects since 1998”
Certifications & Trust Signals
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PQE Group is ISO 9001 certified.
Source
“Our ISO 9001 certification and awards received are a demonstration of our support effectiveness and top quality delivered to our clients.”
Buyer Snapshot
Best for
- Companies seeking FDA 510(k) submission support.
- Medical device and IVD manufacturers targeting the European market.
- Organizations needing to enhance their quality and regulatory compliance.
How engagement typically works
- Direct engagement via website contact form.
- Consultative approach to complex quality projects.
- Support for rolling activities and corporate growth.
Typical deliverables
- FDA 510(k) submission packages.
- CE Marking guidance and support.
- Quality system implementation.
- Regulatory intelligence reports.
- Data integrity and digital governance solutions.
Good to know
- Best when requiring specialized regulatory affairs expertise for US and EU markets.
HQ:
Rockville, United States
Languages:
English
Timezones:
EST, CET
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
26
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital
Engagement Models:
Multitasking teams
Accepting New Clients:
Yes
Supports Estar:
No
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Num510k Submitted:
15000
