Consulting services for Medical Devices including MDSW, SaMD, DTx and AI/ML-Enabled solutions

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NorMed Consulting was founded to address the growing need for expertise in the dynamic field of Medical Devices, particularly focusing on Medical Device Software (MDSW), Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and AI/ML-enabled solutions. We employ a pragmatic and structured approach to streamline the path to market, minimizing burdens without compromising on our top priorities: patient safety and product quality.

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We provide the following services:

Regulatory Strategy

Whether seeking FDA approval, CE or UKCA marking for your medical device, we can provide you with support in both regulatory strategy, submission and interaction with regulatory authorities.

Clinical Development

With several years of experience within Medical Writing and Good Clinical Practice, we can support your Clinical Evaluation including Clinical Development and strategy.

Quality Assurance

We provide Design Assurance services covering all aspects of Design Control, as well as Quality Assurance and Audit support in the development of your Quality Management System (QMS). 

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