Consulting services for Medical Devices including MDSW, SaMD, DTx and AI/ML-Enabled solutions
Alata
Alice
Open Sans
Noto Sans
Bebas Neue
Great Vibes
Rock Salt
Exo
Belgrano
Overlock
Cinzel
Indie Flower
Staatliches
Roboto Slab
Lato
Noto Serif
Open Sans
Montserrat
Ubuntu
Rubik
Delius
Amiri
Montserrat
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.
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).
Copyright NorMed Consulting 2022