About

Regulatory and Quality Management Consulting

At Camneteq, we partner with MedTech innovators as well as established MedTech companies to transform regulatory complexity into a structured, efficient, and value-adding process.
Our expertise in Quality Management Systems (QMS) and Technical Documentation ensures that your products not only meet regulatory requirements but are positioned for successful and sustainable market access.

Quality Management Systems Built for Growth

Camneteq supports you in establishing and evolving a robust, audit-ready QMS aligned with standards such as ISO 13485, EU MDR/IVDR, MDSAP and FDA requirements.

We help you:

  • Design and implement scalable QMS frameworks tailored to your organization and product portfolio
  • Perform gap analyses and remediation to quickly achieve compliance readiness
  • Optimize processes to increase efficiency while maintaining full regulatory control
  • Prepare for audits and inspections, including Notified Bodies and FDA
  • Train your teams to build internal competence and long-term ownership

Our approach ensures your QMS becomes a strategic asset—not just a regulatory requirement.

High-Quality Technical Documentation

Camneteq ensures your Technical Documentation is complete, compliant, and submission-ready, aligned with EU MDR Annex II & III and applicable global expectations.

We support you with:

  • End-to-end Technical File development, from concept to submission
  • Clear structuring and authoring of documentation, including design, manufacturing, and verification data
  • Risk management integration aligned with ISO 14971
  • Clinical and performance documentation, including CER and PMCF
  • Thorough reviews and gap assessments to prevent delays during conformity assessment

Our focus is on creating documentation that tells a clear, coherent, and defensible story of your device’s safety and performance.

A Strategic Partner in Your Development Journey

At Camneteq, we go beyond compliance. We act as a trusted partner, helping you accelerate development and reduce regulatory risk.

With our support, you benefit from:

  • Faster time-to-market through structured and efficient processes
  • Reduced risk of non-compliance and rework
  • Regulatory clarity across global markets
  • Scalable systems that grow with your company

Whether you are a startup building your first QMS or an established company navigating MDR transitions, Camneteq provides practical expertise, hands-on support, and strategic guidance at every stage.

Camneteq Value Proposition

Camneteq bridges quality, regulatory, and business needs—enabling MedTech companies to focus on innovation while we ensure compliance is achieved efficiently, effectively, and sustainably.

Telephone

+46 705 61 25 88

Email

tomas.camnell@camneteq.se

Address

S:t Göransgatan 13, 621 55 Visby, Sweden