Based in Copenhagen we are available for fully remote or hybrid contracts including project based relocation. 

Whether for a 'one time' contract or Master Service Agreement with subsequent Work Orders, we offer flexible solutions that match your company needs.

NorMed Consulting was established to guide manufacturers through the complex and ever-evolving global regulatory landscape, specifically focusing on Medical Device Software. Our firm provides comprehensive services in end-to-end New Product Development for medical devices. We are committed to helping manufacturers navigate the regulatory process in the most efficient manner possible while prioritizing patient safety and product quality.


We possess extensive expertise in preparing submissions in compliance with:

  • 21 CRF, Pat 820 - FDA’s Quality System Regulation (QSR)
  • Regulation (EU) 2017/745 - Medical Device Regulation (MDR)
  • Regulation (EU) 2017/746 - Vitro Diagnostic Regulation (IVDR)
  • The UK’s Medical Device Regulation (UK MDR)
  • The Artificial Intelligence Act - 'AI Act'


Our specialization extends to the following Devices Types:

  • Device Software (MDSW)
  • Software as a Medical Device (SaMD)
  • Software in a Medical Device (SiMD)
  • Digital Therapeutics (DTx)
  • AI/ML-enabled medical devices
  • Combination Products
  • Vitro Diagnostic (IVD) Medical Devices


Contact Us

HOW WE WORK

We aim to provide high flexibility and maximum value for our customers. 

FLEXIBLE CONTRACTS

Whether for a one time assignment or as part of a larger project, we provide flexible contracts that meet your company needs.

WORKING GLOBAL

No matter where in the world, we are available for remote or hybrid work, as well as project based allocation abroad.

PATIENT SAFETY & QUALITY

While keeping patient safety the highest priority, we are focused on creating the highest possible value for our customers, through a LEAN process, as well as a pragmatic and least burdensome approach to market.

COMMUNICATION

We work through open, clear and candid communication with customers and stakeholders, ensuring that knowledge is transferred to empower our customers.

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