Kalms Consulting GmbH Announces Strategic Partnership with QRx Partners
Entering new markets in the MedTech and IVD space comes with a host of challenges—from mastering different regulatory frameworks to establishing operational readiness in unfamiliar territories. At Kalms Consulting GmbH, our mission is to make this process more structured, compliant, and streamlined and thus efficient for our clients.
We are proud to announce a new strategic partnership with QRx Partners, a U.S.-based consulting firm specializing in regulatory, quality, and product development services for medical device and in vitro diagnostics (IVD) companies. This collaboration bridges the gap between Europe and the United States, providing life sciences companies with a truly global market access solution.
Who Are QRx Partners?
Based in Minnesota, QRx Partners delivers customized consulting support for early-stage and scaling MedTech companies across North America. With deep expertise in FDA regulations, quality systems, and clinical engineering, they guide companies through:
- Regulatory strategy and FDA submissions
- Quality management systems and compliance
- Risk management and product development lifecycle support
- Clinical evaluation and post-market activities
Their team of seasoned professionals focuses on “right-sized solutions”—tailored to meet the specific needs of startups and growing firms without overcomplicating the process.
Why This Partnership Matters?
This collaboration with QRx Partners is a natural extension of Kalms Consulting’s strategic vision: to enable international market success for medical technology companies through integrated and expert-driven services at a global scale. While QRx brings hands-on FDA and U.S. market expertise, Kalms Consulting complements this with decades of experience navigating EU medical device/IVD legislation compliance and market entry into Europe.
End-to-End Services – A Cross-Continental Offering
Together, Kalms Consulting and QRx Partners offer a two-way support framework for market expansion:
For U.S.-based companies entering Europe:
- MDR and IVDR compliance guidance
- European market access strategy and Notified Body support
- Risk management and product development lifecycle support
- Local representative services and business advisory
For European companies entering the U.S.:
- Regulatory strategy and 510(k)/De Novo/PMA support
- FDA inspection readiness and QMS implementation
- Risk, design control, and technical documentation
This partnership provides a seamless, well-coordinated pathway for companies navigating the complexities of transatlantic market expansion.
A Unified Vision for Global Growth
Our shared approach is based on removing barriers to international success. By aligning regulatory consulting with product development, risk management, and quality system expertise, Kalms Consulting and QRx Partners ensure that MedTech companies are well-prepared for compliant and successful product launches in both Europe and the United States.
Your Strategic Benefits
- Simplified Compliance: Clear, actionable guidance for navigating U.S. and EU regulatory systems
- Operational Efficiency: Eliminate delays and misalignment through integrated support
- Scalable Solutions: Tailored consulting services that grow with your business
- Global Network: Access to trusted partners, industry know-how, and regulatory authorities
- Continued Collaboration: Ongoing support that adapts with your company’s evolution
- Streamlined approached covering the largest healthcare markets and using all possible synergies while at the same time reducing the effort for project management and communication on your side
Conclusion
This partnership between Kalms Consulting GmbH and QRx Partners marks a new milestone in global collaboration for medical device and IVD companies. With a shared commitment to quality, precision, and regulatory excellence, we deliver a powerful and integrated solution for companies seeking to expand confidently on both sides of the Atlantic.
About The Kalms Group
The Kalms Group is a provider of healthcare market access and medical supply chain solutions. Based in Berlin, the company supports medical device manufacturers, diagnostics, health IT, biotech and lifescience companies in achieving business success across Europe.
The company operates through two main divisions:
Kalms Consulting: With a deep understanding of the European medical device markets, Kalms Consulting helps clients navigate regulatory landscapes, reimbursement pathways and achieve market entry and growth. We connect companies with the relevant stakeholders such as key opinion leaders, medical societies and healthcare authorities. Our focus is on fast and efficient commercialization.
Kalms Operations: This division provides healthcare logistics services designed for start-ups, small, and mid-sized companies. From single deliveries to frequent shipments, Kalms Operations offers flexible and customized logistics solutions to ensure products reach their destinations efficiently and reliably.
Comprehensive Services – A One-Stop Solution
At Kalms Operations, we provide end-to-end support for medical device manufacturers entering the European market. Our services include:
- ISO 13485-compliant 3PL logistics (including cold chain)
- Importer services under MDR/IVDR Article 13
- Virtual back office and customer support
- Maintenance and repair coordination for medical systems
- GDPR representation and more.
Kalms Group is dedicated to delivering innovative solutions and support. The team works closely with clients to understand their needs and provide strategic insights. Whether expanding market presence or streamlining supply chains, Kalms Group is a trusted partner in the healthcare industry.
The image utilized in this article was sourced from unsplash.com in accordance with the license terms of use.
Published on: June 11, 2025
