Novarum MDRQ Consulting is a leading provider of regulatory and quality consulting services for the medical device and digital health industries, with a specialized focus on Software as a Medical Device (SaMD) and AI/ML-based healthcare solutions. With over a decade of experience in global regulatory strategy, our team helps companies navigate complex regulatory landscapes and bring cutting-edge innovations to market.

At Novarum, we partner with medical device companies to develop comprehensive regulatory pathways, ensuring compliance with key markets including US FDA (510(k), De Novo, PMA), EU MDR, UK CA Marking, Australia TGA, and Health Canada. Our expertise also extends to establishing robust Quality Management Systems (QMS) that meet international standards and support product development from concept through commercialization.

Our services include:

Regulatory Strategy Development for medical devices, SaMD, and AI/ML technologies.
Regulatory Submissions and Market Authorization in global markets.
Clinical Decision Support Systems Compliance.
Setup and management of Quality Assurance (QA) and Regulatory Affairs (RA) functions.
Guidance on navigating reimbursement landscapes in the US, EU, and UK (including DTAC).
We also work extensively with outsourced global teams, offering expertise in managing relationships with contract manufacturers, clinical research organizations (CROs), test houses, and third-party logistics providers (3PLs), ensuring seamless global operations.

At Novarum MDRQ Consulting, we are passionate about supporting healthcare innovators through pro-bono mentoring and advising startups, as well as serving as educators in the regulatory and medical device space.

Novarum MDRQ Consulting

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