RQM+
RQM+: FDA Regulatory Consulting for MedTech & Software Expertise
RQM+ is a full-service MedTech CRO specializing in FDA regulatory consulting, with a strong focus on software expertise. They assist medical device companies in navigating complex FDA regulatory pathways, including 510(k) submissions, De Novo applications, and Premarket Approval (PMA). RQM+ serves clients globally and helps them achieve successful market access.
About
**Who they are**
RQM+ is a regulatory and quality consulting firm with over 50 years of direct FDA experience, dedicated to helping MedTech companies navigate complex challenges. They position themselves as a reliable and flexible partner for bringing life-changing medical technologies to patients.
**Expertise & scope**
* Regulatory and quality consulting for MedTech companies.
* Expertise in Medical Devices, In Vitro Diagnostics, Software-Enabled Products, Combination Products, and Companion Diagnostics (CDx).
* Support for Emerging MedTech & Startups.
* Assistance with regulatory and quality, laboratory, clinical, and reimbursement challenges.
* Solutions for product development through post-market support.
* Guidance on global compliance and staying ahead of evolving standards.
* Services for launching, scaling, remediating, or acquiring products.
**Reputation / proof points**
* Over 50 years of direct FDA experience.
* Offices in the United States (HQ) and Europe (Switzerland, Germany).
RQM+ is a regulatory and quality consulting firm with over 50 years of direct FDA experience, dedicated to helping MedTech companies navigate complex challenges. They position themselves as a reliable and flexible partner for bringing life-changing medical technologies to patients.
**Expertise & scope**
* Regulatory and quality consulting for MedTech companies.
* Expertise in Medical Devices, In Vitro Diagnostics, Software-Enabled Products, Combination Products, and Companion Diagnostics (CDx).
* Support for Emerging MedTech & Startups.
* Assistance with regulatory and quality, laboratory, clinical, and reimbursement challenges.
* Solutions for product development through post-market support.
* Guidance on global compliance and staying ahead of evolving standards.
* Services for launching, scaling, remediating, or acquiring products.
**Reputation / proof points**
* Over 50 years of direct FDA experience.
* Offices in the United States (HQ) and Europe (Switzerland, Germany).
Additional information
RQM+ emphasizes an integrated approach to regulatory affairs and quality assurance, aiming to keep product pipelines on track while adapting to changing global standards. They utilize a 'MedTech Regulatory Risk Map' to help clients diagnose regional risk factors across the product life cycle, illustrating how decisions can create diverging global realities. This tool is designed to help innovators achieve and maintain compliance in the dynamic MedTech market.
Key Highlights
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Over 50 years of direct FDA experience.
Source
“Backed by 50+ years of direct FDA experience, we offer MedTech regulatory affairs and quality assurance solutions...”
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Expertise spans Medical Devices, In Vitro Diagnostics, Software-Enabled Products, Combination Products, and Companion Diagnostics (CDx).
Source
“Medical DevicesIn Vitro DiagnosticsSoftware-Enabled ProductsCombination ProductsCompanion Diagnostics (CDx)”
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Offers integrated regulatory and quality solutions for MedTech success.
Source
“Integrated and customized RA/QA solutions that drive MedTech success.”
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Provides support for emerging MedTech and startups.
Source
“Emerging MedTech & Startups”
Certifications & Trust Signals
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Headquartered in the United States with additional offices in Europe.
Source
“United States HQ; EuropeHQ; Switzerland Office; Germany Frankfurt Office; Germany AhlenOffice”
Buyer Snapshot
Best for
- MedTech companies seeking regulatory and quality consulting.
- Innovators needing to navigate global compliance.
- Companies focused on Medical Devices, IVDs, and Software-Enabled Products.
How engagement typically works
- Consultation request via form submission.
- Response within 1-2 business days.
- End-to-end support from product development to post-market.
Typical deliverables
- Regulatory strategy and execution.
- Quality system implementation and remediation.
- Global compliance guidance.
- Market access support.
Good to know
- Best when requiring specialized expertise in MedTech regulatory affairs and quality assurance.
HQ:
Cary, United States
Languages:
English
Timezones:
UTC-5
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), 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, SaMD, Combination product
Years Experience:
50
Ex FDA:
Yes
Ex Notified Body:
Yes
Ex Big Medtech:
No
Engagement Models:
Outsourcing, Consulting, Staff Augmentation
Accepting New Clients:
Yes
Supports Estar:
No
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Response Time Hours:
48
