RQM+
RQM+ is The MedTech CRO, offering comprehensive regulatory, quality, laboratory, clinical, and reimbursement solutions for medical device manufacturers. They accelerate innovation from concept to patient impact, ensuring faster, safer, and better market access.
RQM+ is a full-service MedTech CRO that partners with companies to navigate the complexities of bringing life-changing medical technologies to patients. They provide tailored expertise across the entire product life cycle, including regulatory compliance, quality assurance, FDA-recognized laboratory services, clinical trial management, and reimbursement strategies. With a focus on accelerating innovation, RQM+ helps clients achieve faster time to market, lower risk, and comprehensive support. Their services cover a wide range of MedTech products, including medical devices, in vitro diagnostics, software-enabled products, combination products, and companion diagnostics. Their team of experienced professionals offers a client-centric approach, ensuring solutions are right-sized and aligned with program goals. RQM+ is committed to being a trusted and valued partner, strengthening the MedTech industry through expert insights and active participation in regulatory and standards development.
About
**Who they are**
RQM+ is a MedTech CRO that provides comprehensive regulatory, quality, laboratory, clinical, and reimbursement solutions for medical device manufacturers. They aim to accelerate innovation from concept to patient impact, ensuring faster, safer, and better market access.
**Expertise & scope**
* Regulatory, quality, laboratory, clinical, and reimbursement solutions for medical devices.
* Expertise in Medical Devices, In Vitro Diagnostics, Software-Enabled Products, Combination Products, Companion Diagnostics (CDx), and Emerging MedTech & Startups.
* Assistance with biological evaluation processes for medical device development, including understanding updates to ISO 10993-1.
* Guidance on risk management processes and their interrelation with biological evaluation, incorporating elements like reasonably foreseeable misuse.
* Support in re-evaluating biological evaluation processes based on updated device categories and considerations for contact duration.
**Reputation / proof points**
* Operates offices in the United States (HQ), United Kingdom, and Switzerland, with a lab presence through Jordi Labs, an RQM+ Company.
* Addresses provided include locations in Cary, NC (US), Altrincham, Cheshire (UK), Frankfurt (Germany), and Ahlen (Germany).
RQM+ is a MedTech CRO that provides comprehensive regulatory, quality, laboratory, clinical, and reimbursement solutions for medical device manufacturers. They aim to accelerate innovation from concept to patient impact, ensuring faster, safer, and better market access.
**Expertise & scope**
* Regulatory, quality, laboratory, clinical, and reimbursement solutions for medical devices.
* Expertise in Medical Devices, In Vitro Diagnostics, Software-Enabled Products, Combination Products, Companion Diagnostics (CDx), and Emerging MedTech & Startups.
* Assistance with biological evaluation processes for medical device development, including understanding updates to ISO 10993-1.
* Guidance on risk management processes and their interrelation with biological evaluation, incorporating elements like reasonably foreseeable misuse.
* Support in re-evaluating biological evaluation processes based on updated device categories and considerations for contact duration.
**Reputation / proof points**
* Operates offices in the United States (HQ), United Kingdom, and Switzerland, with a lab presence through Jordi Labs, an RQM+ Company.
* Addresses provided include locations in Cary, NC (US), Altrincham, Cheshire (UK), Frankfurt (Germany), and Ahlen (Germany).
Additional information
RQM+ emphasizes the interconnectedness of biological evaluation and risk management processes, particularly in light of the 6th edition of ISO 10993-1. They highlight that while the new edition may not mandate new testing, manufacturers must assess existing processes against the revised framework. Key updates include changes to categorization terms, methods for calculating contact duration, and the shift from 'biological endpoints' to 'biological effects.' RQM+ can assist in navigating these changes, ensuring that manufacturers consider elements like reasonably foreseeable misuse and updated device category considerations within their ISO 14971 risk management framework. Their approach aims to help clients proactively address regulatory expectations and avoid compliance challenges.
Key Highlights
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RQM+ offers comprehensive regulatory, quality, laboratory, clinical, and reimbursement solutions for medical device manufacturers.
Source
“offering comprehensive regulatory, quality, laboratory, clinical, and reimbursement solutions for medical device manufacturers.”
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They provide expertise in various MedTech categories including Medical Devices, In Vitro Diagnostics, Software-Enabled Products, Combination Products, Companion Diagnostics (CDx), and Emerging MedTech & Startups.
Source
“Medical DevicesIn Vitro DiagnosticsSoftware-Enabled ProductsCombination ProductsCompanion Diagnostics (CDx)Emerging MedTech & Startups”
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RQM+ helps clients navigate updates to ISO 10993-1, emphasizing the integration of biological evaluation with risk management processes.
Source
“The 6th edition of ISO 10993-1 is published! It brings significant updates for biological evaluation processes in medical device development.”
Certifications & Trust Signals
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RQM+ operates multiple offices, including headquarters in the United States, and international locations in the UK and Germany, alongside a lab presence via Jordi Labs.
Source
“United States HQ; EuropeHQ; Switzerland Office; United States Lab Jordi Labs, an RQM+ Company; Germany Frankfurt Office; Germany AhlenOffice”
Buyer Snapshot
Best for
- Medical device manufacturers seeking comprehensive regulatory and quality support.
- Companies navigating complex biological evaluation requirements, including ISO 10993 updates.
- Startups and emerging MedTech companies requiring guidance from concept to market access.
How engagement typically works
- Collaborative partnership to overcome regulatory and quality challenges.
- Flexible approach to client success.
- Responsive communication with a stated response time of 1-2 business days for inquiries.
Typical deliverables
- Regulatory strategy and submissions.
- Quality system development and implementation.
- Laboratory testing support and biological evaluation reports.
- Clinical trial support.
- Reimbursement strategies.
Good to know
- Best when clients require end-to-end support for medical device development and market access.
- Best when clients need to ensure compliance with evolving standards like ISO 10993.
HQ:
Cary, US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Industries:
Medical Devices
Pricing model:
Custom pricing
Iso10993 Standards Supported:
ISO 10993-1
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity, Biodegradation, Other
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
RQM+ offers laboratory services, including biocompatibility testing, to ensure medical devices meet global standards. They provide expertise across various device types and therapeutic areas, accelerating innovation from concept to patient impact. Their services cover regulatory and quality expertise, clinical trials, and reimbursement strategies.
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Quote SLA:
3-5 business days
Nda Support:
Yes
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1
Test Types Offered
Biological evaluation
Contact Types Supported
N/A
Duration Types Supported
N/A
Lead Time Band
Start in 1-2 weeks
Quote SLA
1-2 business days
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
N/A
