Regulatory & Clinical Strategy for Medical Device Software (MDSW) and AI/ML-enabled MedTech
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 supports startups and small to mid-sized MedTech companies with Regulatory Strategy, Clinical Evaluation, development of Quality Management Systems (QMS), and Design Control activities under the EU MDR and FDA QMSR.
Specialized expertise within Medical Device Software (MDSW) including Software as a Medical Device (SaMD) and Sofware in a Medical Device (SiMD), as well as AI/ML-enabled Medical Devices.
Specialized Expertise
Regulatory Strategy
Support for MDR, FDA, and UKCA regulatory pathways for Medical Device Software (MDSW), AI/ML-enabled technologies, and interaction with regulatory authorities.
Clinical Development & SW Compliance
Support for Clinical Evaluation (CER/CEP), IEC 62304 software lifecycle activities, usability engineering, risk management, and technical documentation development.
Quality Systems & Market Access
Pragmatic support for Quality Management Systems (QMS), Design Controls, gap assessments, audit preparation, and market access activities tailored to MedTech startups and SMEs.