Experts with the
Medical Regulatory Journey
Digital Health Works is a commercialization agency for digital health, MedTech, and medical device ventures.
We are a team of veteran medical regulatory experts from the US and Europe.
We manage quality systems, FDA clearances, UK approvals, and CE marking for startups, ventures, and institutions.
We are international medical regulatory experts.
Digital Health Works facilitates the launch of medical devices in the US, EU, and UK markets by leveraging our extensive experience with FDA, MHRA, and EMA regulations.
We bring years of hands-on experience in regulatory submissions and product approvals. Our advisors work closely with our clients, aligning business and operational needs with the strategic objective of obtaining timely approvals from relevant regulatory authorities.
Assessment and planning: This is where the journey starts. We assist new ventures who need to understand the philosophy behind building an ISO 13485-compliant quality management system (QMS). We also help those already underway to sort out issues and problems with their work to date.
For companies with approval in one market, we can help migrate that approval to another: from the EU or UK to the US, from the US to Europe, or from LATAM or Singapore.
By commissioning Digital Health Works, medical device companies gain access to a veteran team of professionals and critical external resources—people who can help your company get organized and efficiently obtain your product’s approval in the right markets.
Our mission is to help our clients connect their medical innovations with the people who need them most.
