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 assists medical device manufacturers in navigating regulatory, quality, laboratory, clinical, and reimbursement challenges. They aim to accelerate the path from concept to patient impact.

**Expertise & scope**
* Regulatory and quality solutions
* Laboratory services
* Clinical support
* Reimbursement strategies
* Expertise in Medical Devices, In Vitro Diagnostics, Software-Enabled Products, Combination Products, Companion Diagnostics (CDx), and Emerging MedTech & Startups.

**Reputation / proof points**
* Offers comprehensive solutions for faster, safer, and better market access.
* Operates with a commitment to client success, positioning themselves as a reliable and flexible partner.
* Provides consultation response within 1–2 business days.

Additional information

RQM+ focuses on overcoming complex challenges within the medical technology sector. Their approach integrates various critical functions, including regulatory compliance, quality management, laboratory testing, clinical trials, and reimbursement planning. This holistic strategy is designed to streamline the product development lifecycle, enabling companies to bring innovative medical technologies to patients more efficiently. They emphasize a partnership model, working closely with clients to achieve successful market entry.

Key Highlights

  • Offers 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.”
  • Specializes in Medical Devices, In Vitro Diagnostics, Software-Enabled Products, Combination Products, Companion Diagnostics (CDx), and Emerging MedTech & Startups. Source
    “Medical Devices In Vitro Diagnostics Software-Enabled Products Combination Products Companion Diagnostics (CDx) Emerging MedTech & Startups”
  • Aims to accelerate innovation from concept to patient impact, ensuring faster, safer, and better market access. Source
    “They accelerate innovation from concept to patient impact, ensuring faster, safer, and better market access.”

Certifications & Trust Signals

  • Operates as The MedTech CRO, indicating a comprehensive service offering. Source
    “RQM+ is The MedTech CRO, offering comprehensive regulatory, quality, laboratory, clinical, and reimbursement solutions for medical device manufacturers.”
  • Has multiple office locations, including headquarters in the United States and offices in the United Kingdom and Switzerland. Source
    “United States HQ EuropeHQ Switzerland Office”

Buyer Snapshot

Best for
  • Medical device manufacturers seeking end-to-end support
  • Companies needing to navigate complex regulatory landscapes
  • Startups and emerging MedTech companies
How engagement typically works
  • Partnership-driven approach
  • Consultation and tailored solutions
  • Focus on accelerating market access
Typical deliverables
  • Regulatory strategy and submissions
  • Quality system development and implementation
  • Laboratory testing reports
  • Clinical trial support
  • Reimbursement analysis and planning
Good to know
  • Best when requiring integrated 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
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