
Digital Health Works
Digital Health Works is a commercialization agency for digital health and medical device ventures.
Commercializing health technologies requires thoughtful steps and strategies to ensure long-term viability and success.
A key part of building and growing that business is ensuring compliance with relevant regulatory requirements.
We bring years of hands-on experience in regulatory submissions and product approvals in the UK, Europe, and the US. Our advisors work closely with our early-stage clients, aligning business and operational needs with the strategic objective of obtaining timely approvals from relevant regulatory authorities.
We are not just consultants that come in and do the work for you, our goal is to coach your team through the necessary documentation and regulatory requirements to ensure you are on the right track, in the most affordable way, setting you up for long-term success.
From setting up and implementing your first quality management system (QMS), to guiding you through audits and negotiations, through to device and SaMD product submissions and obtaining your market certification, our team have extensive experience with FDA, MHRA, and EMA regulations.
Services We Offer:
- Regulatory Affairs (FDA, MHRA, EMA)
- Quality Management System setup and implementation (ISO 13485-compliant)
- Initial Regulatory Assessment (FDA, MHRA, EMA)
- Device and SaMD Product Submissions (510(k), MDR, IVDR)
- Post Market Surveillance
Support Offered:
We bring years of hands-on experience in regulatory submissions and product approvals in the UK, Europe, and the US. Our advisors work closely with our early-stage clients, aligning business and operational needs with the strategic objective of obtaining timely approvals from relevant regulatory authorities.
We are not just consultants that come in and do the work for you, our goal is to coach your team through the necessary documentation and regulatory requirements to ensure you are on the right track, in the most affordable way, setting you up for long-term success.
From setting up and implementing your first quality management system (QMS), to guiding you through audits and negotiations, through to device and SaMD product submissions and obtaining your market certification, our team have extensive experience with FDA, MHRA, and EMA regulations.
We specialize in supporting early-stage ventures expand internationally, even for companies with approval in one market, we can help migrate that approval to another, from the EU or UK to the US for example.
Eligibility Criteria:
- Product type: Digital health, Medical Device, Software as a Medical Device, In-vitro Diagnostics
- Venture stage: pre-product (idea assessment), early-stage (idea development), pre-commercialisation (evaluation), commercialisation stage (commercialisation, spread and adoption)
Regulatory and quality should factor in to all the steps of the innovation pathway, from a simple evaluation and assessment of regulatory risks during the pre-product or idea phase, through to full product submissions to the relevant regulatory authorities during commercialisation stage, medical device and digital health products must be built on a strong foundation to ensure safety and compliance. This includes a robust quality and regulatory strategy.