MANKAINDDeveloping a wearable ECG recorder with MANKAIND
A team wants to develop a wearable ECG recorder. It starts by defining three things.
The team’s device brief
- Intended purpose
- Record ECG during everyday activities for later review by healthcare professionals.
- Users
- Adults recording at home, and clinicians reviewing their recordings.
- First target market
- European Union
From this brief, MANKAIND proposes a starting programme covering the whole development effort: engineering activities, initial document drafts, dependencies and reviews, alongside regulatory assessment, risk management, verification and validation.
The European Union target shapes that proposal: safety and performance requirements, clinical evaluation, labelling and post-market planning develop alongside the engineering work.
The team reviews the proposal and begins developing the device with MANKAIND. Engineers investigate design options, work through calculations, refine requirements and prepare tests. The documents and their connections develop as that work progresses.
One early engineering question
What would it take for the first prototype to record for 24 hours?
That question reaches across battery capacity, data storage, recording software and the information a clinician needs if recording stops early. Initial power and storage estimates help the team investigate a prototype direction. Measurements and testing will establish how the device actually performs.
European Union · EU MDR
Design and development records
These connected records build the device’s EU technical documentation as engineering progresses. Requirements, design decisions and risk controls sit alongside clinical evaluation, labelling and lifecycle plans.
This interactive example shows 31 selected records organised by development phase. Drafts and planned evidence contribute to the broader documentation described in the EU index; they do not represent a completed conformity assessment.
Start with “Hardware design” to inspect the power and storage analysis. Follow the connections through the recording requirements, interruption risks and planned verification—or open any document that interests you.
Open the “EU documentation index” to see how the records contribute to the EU MDR documentation requirements and where evidence is still needed.
Open a document to read its contents, then use its related links to explore connected work.
EU technical documentation · In development
Connected development records, draft EU documentation and planned evidence. Reviews and test results remain outstanding. Lifecycle plans and the documentation index begin during development.Click a document to read it and follow its connections.
Concept
Planning
Design input
Design output
Verification & validation
Transfer & lifecycle
Documents are grouped by phase. Connections can run within and across phases.
The next decision starts from here
A 24-hour recording target affects more than battery capacity. It shapes storage requirements, interruption handling and the tests the team needs to run.
The next task in this example is to measure power during acquisition, storage and transfer. Those findings will help the team refine the design and review its related requirements, risks and verification plans.
As the team develops the device with MANKAIND, its development records and EU technical documentation grow alongside it—connecting the reasoning behind decisions, the work still to do and the evidence gathered through testing.
What would the starting programme for your device look like?
Bring your intended purpose, users and target markets to a medical-device demo.