Medical device regulation platf

Building a 4x faster assessment tool for software and clinical medical device certification

My role: Senior designer

Team: 1 product manager, 3 designers, 5 full stack engineers

Year: 2025

My role

Scarlet were building an internal assessment tool for certifying medical devices with ISO 13485, EUMDR, UKMDR amongst other certifications.
Scarlet had just pivoted from an evergreen style of platform where a company looking for certification would keep an up to date database of their devices and business, to an unstructured submission platform.

Successes

  • Launch V1 of the web tool for technical assessments

  • Build a UI capable of displaying and organising one to hundreds of regulatory requirements for assessing.

What is medical device regulation

It’s the system of laws, requirements, and oversight that ensures medical devices are safe to use.

The challenge
There are 1 - many requirements that make up each regulation. For example.
EUMDR = 1 regulation

  1. Contains 123 Articles + 17 Annexes

  2. Annex I (GSPRs) alone = 23 “umbrella” requirements, which break down into ~200+ specific requirements

  3. Across the full text, there are several hundred distinct obligations that a medical device manufacturer must comply with, depending on device class, type, and intended use.

Each one of those obligations needs to be assessed in one way or another against evidence provided by the device manufacturer.

Feedback

Feedback was collected and presented back to stakeholders with summaries and links provided to anyone who couldn’t attend. I then worked with our product managers to link the feedback to any existing ticket and create new tickets where the feedback aligned with company priorities.

Design and implementation

With a launch date of the 6th of June we managed to design and build with continuous testing across all user groups the chat room, launch pages for customers, patient list views & patient management pages and features.

App screens

Work lists, user lookup, and account pages.

Patient landing pages

Therapy interface