Consulting services for Medical Devices including 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 established to meet the increased demand for support in the ever-changing landscape of Medical Devices and in particular Medical Device Software, SaMD, DTx and AI/ML enabled solutions. We follow a pragmatic and structured approach, ensuring the least burdensome path to market while keeping patient safety and product quality the top priority.
We provide the following services:
Regulatory Strategy
Whether seeking FDA approval, CE or UKCA mark 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 support in the development of your QMS for New Product Development.
Copyright NorMed Consulting 2022