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 focus on accelerating innovation from concept to patient impact, aiming for faster, safer, and better market access.
**Expertise & scope**
* Offers solutions for regulatory and quality, laboratory, clinical, and reimbursement challenges.
* Supports a range of product types including Medical Devices, In Vitro Diagnostics, Software-Enabled Products, Combination Products, and Companion Diagnostics (CDx).
* Specializes in emerging MedTech and startups.
* Provides expertise in navigating updates to standards such as ISO 10993-1, including the 6th edition, emphasizing the interrelation between biological evaluation and risk management processes.
* Assists manufacturers in assessing existing processes against revised frameworks and considering factors like reasonably foreseeable misuse.
**Reputation / proof points**
* Operates with offices in the United States (HQ in Cary, NC) and the United Kingdom (Altrincham, Cheshire).
* Includes a laboratory division, Jordi Labs, an RQM+ Company.
* Has an office in Switzerland and in Germany (Frankfurt and Ahlen).
RQM+ is a MedTech CRO that provides comprehensive regulatory, quality, laboratory, clinical, and reimbursement solutions for medical device manufacturers. They focus on accelerating innovation from concept to patient impact, aiming for faster, safer, and better market access.
**Expertise & scope**
* Offers solutions for regulatory and quality, laboratory, clinical, and reimbursement challenges.
* Supports a range of product types including Medical Devices, In Vitro Diagnostics, Software-Enabled Products, Combination Products, and Companion Diagnostics (CDx).
* Specializes in emerging MedTech and startups.
* Provides expertise in navigating updates to standards such as ISO 10993-1, including the 6th edition, emphasizing the interrelation between biological evaluation and risk management processes.
* Assists manufacturers in assessing existing processes against revised frameworks and considering factors like reasonably foreseeable misuse.
**Reputation / proof points**
* Operates with offices in the United States (HQ in Cary, NC) and the United Kingdom (Altrincham, Cheshire).
* Includes a laboratory division, Jordi Labs, an RQM+ Company.
* Has an office in Switzerland and in Germany (Frankfurt and Ahlen).
Additional information
RQM+ emphasizes the critical link between biological evaluation and risk management processes, particularly in light of updated standards like ISO 10993-1 (6th Edition). They advise manufacturers to proactively assess their current processes against revised frameworks, noting that elements like 'reasonably foreseeable misuse' should be integrated, aligning with established ISO 14971 risk management practices. The company highlights changes in categorization terms and contact duration calculations, which may significantly impact devices with transient or intermittent contact. RQM+ positions itself as a partner to help companies navigate these evolving 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
“We help MedTech companies overcome regulatory and quality, laboratory, clinical, and reimbursement challenges.”
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The company provides expertise in navigating updates to ISO 10993-1, including the 6th edition, and its integration 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.”
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RQM+ supports a wide range of product types, including Medical Devices, In Vitro Diagnostics, Software-Enabled Products, and Combination Products.
Source
“Medical DevicesIn Vitro DiagnosticsSoftware-Enabled ProductsCombination ProductsCompanion Diagnostics (CDx)Emerging MedTech & Startups”
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They have a global presence with offices in the United States, United Kingdom, Switzerland, and Germany.
Source
“United States HQ; EuropeHQ; Switzerland Office; Germany Frankfurt Office; Germany AhlenOffice”
Certifications & Trust Signals
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RQM+ operates as a MedTech CRO, indicating a specialized focus within the medical technology sector.
Source
“RQM+ is The MedTech CRO, offering comprehensive regulatory, quality, laboratory, clinical, and reimbursement solutions”
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Includes Jordi Labs, an RQM+ Company, suggesting integrated laboratory capabilities.
Source
“United States Lab Jordi Labs, an RQM+ Company”
Buyer Snapshot
Best for
- Medical device manufacturers seeking comprehensive regulatory and quality support.
- Companies navigating complex standards like ISO 10993 and ISO 14971.
- Emerging MedTech and startups requiring guidance from concept to market.
How engagement typically works
- Collaborative partnership to overcome specific challenges.
- Proactive planning and guidance to stay ahead of regulatory expectations.
Typical deliverables
- Regulatory strategy and submissions.
- Quality system development and implementation.
- Laboratory testing and evaluation reports.
- Clinical trial support.
- Reimbursement strategy.
Good to know
- Best when clients require integrated solutions across regulatory, quality, and laboratory services.
HQ:
Cary, US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Industries:
Medical Devices
Pricing model:
Custom pricing
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-18
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Hemocompatibility, Pyrogenicity, Biodegradation
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 the product life cycle, from concept to post-market.
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Quote SLA:
1-2 weeks
Nda Support:
Yes
Regions Served:
United States, United Kingdom, Switzerland, Germany
Lead Time Band:
Start in 0-2 weeks
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1
Test Types Offered
Biological evaluation
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 0-2 weeks
Quote SLA
1-2 business days
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
Custom
