CRO Kottmann
RQM+ is a MedTech-focused contract research organization providing integrated regulatory, clinical, lab/material science, and reimbursement services to medical device, IVD, SaMD, combination product, and companion diagnostic companies across North America and Europe.
- Company typePrivate
- Founded2008
- HeadquartersHamm, Germany
- Headcount11–50
- GTM typeB2B
- OfferingServices
What CRO Kottmann does
RQM+ (operating under CRO Kottmann-related entities) is a MedTech-focused Contract Research Organization that delivers four integrated service lines: Regulatory & Quality consulting, Clinical Trials management, Lab & Material Science services (including ISO 10993-18 E&L testing and chemical characterization), and Reimbursement strategy. The firm serves medical device, in vitro diagnostic, software-enabled product (SaMD), combination product, companion diagnostic, women's health, and emerging MedTech/startup clients across North America and Europe, with US headquarters in Cary, NC and European headquarters in Altrincham, UK.
The underlying technology and intellectual capital are concentrated in regulatory expertise frameworks, chemical characterization laboratory capabilities, and clinical trial methodologies — including emerging frameworks for AI-enabled device validation, machine-learning-assisted E&L testing, and risk-based monitoring using AI, sensors, and hybrid trial designs. The firm holds BSI ISO 9001 Quality Management certification (certificate FS-565132, expiry 2027) and is a recognized RAPS Premium Solutions Partner, providing externally validated credibility in a category where compliance credentials are central to client selection.
The commercial model is a sales-led, direct-expert-engagement GTM with no self-service or marketplace channels. Pricing is quote-based and not publicly disclosed. The firm supplements direct sales with an extensive content marketing apparatus — resource library, webinars, the RQM+ Live! podcast, an email newsletter, and event participation — that functions as top-of-funnel demand generation targeted at MedTech professionals. Revenue is generated through project-based professional services engagements across all four service lines, with primary emphasis on regulatory and quality consulting for medical devices.
CRO Kottmann firmographics
Firmographics- Name
- CRO Kottmann
- Legal name
- RQM+
- Website
- https://cro-kottmann.de
- Company type
- Private
- Founded year
- 2008
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- RQM+ is a MedTech-focused contract research organization providing integrated regulatory, clinical, lab/material science, and reimbursement services to medical device, IVD, SaMD, combination product, and companion diagnostic companies across North America and Europe.
- Ownership category
- akta.pro rank
CRO Kottmann industry classification
Industry- Product category
- Medical Device CRO Services
- NAICS
- Scientific Research and Development Services (5417)
- SIC
- Services-Management Consulting Services (8742)
- akta.pro primary industry
- Clinical CROs (Phase I–IV) (HLAGAAAA)
- akta.pro secondary industry
- Real-World Evidence (RWE), HEOR & Epidemiology CROs (HLAGAAAK)
Keywords
Where CRO Kottmann is headquartered
LocationHeadquarters
- HQ city
- Hamm
- HQ country
- Germany
- HQ region
- Europe
Offices2 records
Markets served
CRO Kottmann business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- Regulatory & Quality Consulting: Project-based consulting engagements for regulatory strategy, quality management, and compliance services for medical devices, IVDs, and combination products
- Clinical Trials Services: Clinical investigation and trial management services including IDE submissions and clinical evidence generation
- Lab & Material Science Services: Laboratory testing services including extractables & leachables (E&L) testing, chemical characterization, and material science analysis
- Reimbursement Strategy: Reimbursement consulting services to help MedTech companies achieve coverage, payment, and adoption of their products
Go-to-market motion1 record
Distribution channels1 record
Marketing channels7 records
CRO Kottmann product offering
Product offeringCore offering
CRO Kottmann (operating as RQM+) is a MedTech contract research organization that delivers an integrated suite of regulatory and quality consulting, clinical trial management, laboratory and material science testing, and reimbursement strategy services. It supports medical device, IVD, software-enabled, combination product, and companion diagnostic manufacturers across the full product lifecycle, from regulatory strategy through commercialization.
Product overview
RQM+ is a MedTech Contract Research Organization (CRO) offering an integrated suite of regulatory, clinical, laboratory, and reimbursement services. The company provides four core service areas: Regulatory & Quality consulting, Clinical Trials management, Lab & Material Science services, and Reimbursement strategy support. These services span medical devices, in vitro diagnostics, software-enabled products, combination products, and companion diagnostics. The company also offers free educational resources including white papers, case studies, webinars, and a podcast series.
Differentiator
Problem solved
Functional benefit
Products and services
- Regulatory & Quality Regulatory strategy and quality management solutions for medical device, IVD, software-enabled, combination product, and companion diagnostic manufacturers, including FDA/CE submission support, quality systems, and compliance consulting.
- Clinical Trials Clinical investigation and trial management services for medical devices and MedTech products, including study design, execution, IDE submissions, monitoring, and clinical evidence generation.
- Lab & Material Science Laboratory testing and material science services including chemical characterization, extractables and leachables (E&L) testing per ISO 10993-18, and biocompatibility assessment to support regulatory submissions and compliance.
- Reimbursement Reimbursement strategy and market access consulting to help MedTech companies achieve coverage, payment, and adoption of their products across payer landscapes.
Quantifiable outcome
- Rescued stalled IDE submissions via advanced chemical characterization
Companies that use CRO Kottmann
Customer profileSegments7 records
Ideal customer profiles4 records
CRO Kottmann technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
CRO Kottmann partnerships and signals
Strategic signalRecent moves6 records
Expansion highlights5 records
CRO Kottmann competitors and assessment
Company assessmentDirect peers
- Medpace: Medpace is a mid-sized clinical CRO with growing MedTech capabilities alongside its core pharma/biotech business. Comparable in clinical trial execution services and overlapping in regulatory and clinical evidence generation for medical devices.
- NAMSA: NAMSA is the most established pure-play MedTech CRO, offering regulatory, clinical, and laboratory testing services for medical devices. Direct overlap with RQM+ across all four service lines and the same customer base of medical device manufacturers.
- Veranex: Veranex is a MedTech-focused CRO and consulting firm providing regulatory, clinical, design, and engineering services. Comparable as a vertically specialized MedTech services provider targeting similar device and diagnostic manufacturers.
Broad incumbents
- ICON plc: ICON is one of the largest global clinical CROs serving pharma, biotech, and medical device clients. Comparable as a clinical trials competitor, though broader and more pharma-focused than RQM+.
- IQVIA: IQVIA is the world's largest CRO with significant MedTech regulatory and clinical capabilities. Overlaps with RQM+ in clinical trials and regulatory consulting, but operates at much greater scale across all therapeutic areas.
- McKinsey (MedTech Practice): McKinsey's MedTech practice provides strategic and regulatory advisory to medical device companies, including market access and reimbursement strategy. Comparable to RQM+'s reimbursement and market access service line, though part of a broader management consulting portfolio.
- WuXi AppTec: WuXi AppTec provides global CRO and laboratory services including for medical devices and diagnostics. Comparable as a comprehensive testing and clinical services competitor, though primarily known for biologics/pharma.
- Labcorp: Labcorp (including its Drug Development / Clinical Development business) operates a large central lab and CRO serving MedTech and pharma. Overlaps with RQM+ in laboratory testing and clinical trial services.
Emerging players
- The Weinberg Group: The Weinberg Group is a regulatory and quality consulting firm serving medical device and pharmaceutical clients. Comparable as a regulatory consulting competitor with overlapping FDA submission and quality system expertise.
- Biologics Consulting Group: Biologics Consulting Group provides regulatory and quality consulting for biologics, devices, and combination products. Comparable to RQM+'s regulatory consulting practice with similar FDA-focused expertise, though smaller in scale.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
CRO Kottmann social profiles
Digital presenceCRO Kottmann compliance and trust
Trust signalCompliance2 records
CRO Kottmann financial estimates
Financial estimateRevenue estimate
Valuation estimate
CRO Kottmann leadership team
Management profileNumber of profiles
CRO Kottmann funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
CRO Kottmann M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about CRO Kottmann
What does CRO Kottmann do?
CRO Kottmann (operating as RQM+) is a MedTech contract research organization that delivers an integrated suite of regulatory and quality consulting, clinical trial management, laboratory and material science testing, and reimbursement strategy services. It supports medical device, IVD, software-enabled, combination product, and companion diagnostic manufacturers across the full product lifecycle, from regulatory strategy through commercialization.
Is CRO Kottmann a public or private company?
CRO Kottmann is a private company. It is classified as unknown and is currently operating.
When was CRO Kottmann founded?
CRO Kottmann was founded in 2008. It employs 11 to 50 people.
Where is CRO Kottmann based?
CRO Kottmann is headquartered in Hamm, Germany, in the Europe region.
How does CRO Kottmann make money?
Four revenue lines are on record. Regulatory & Quality Consulting is the primary driver. The others are clinical Trials Services, lab & Material Science Services and reimbursement Strategy.
Who are CRO Kottmann's main competitors?
Direct peers on record are Medpace, NAMSA and Veranex. Broad incumbents are ICON plc, IQVIA, McKinsey (MedTech Practice), WuXi AppTec and Labcorp. Emerging players are The Weinberg Group and Biologics Consulting Group.
Does CRO Kottmann have an API?
No public API is recorded for CRO Kottmann.
What industry is CRO Kottmann in?
CRO Kottmann's product category is Medical Device CRO Services. Its primary akta.pro industry code is HLAGAAAA, Clinical CROs (Phase I–IV), with a secondary code of HLAGAAAK, Real-World Evidence (RWE), HEOR & Epidemiology CROs. Its NAICS code is 5417 and its SIC code is 8742.