Knowledge base

Grid Pad 15 – A Class 1 Medical Device

We have built the Grid Pad 15 to meet the requirements of the Medical Device Regulations (MDR) laid out by the EU. It is classified as a class 1 medical device.

This requires us to test the Grid Pad rigorously to ensure it is tough and durable.

How do we do this?

Ensuring the Grid Pad 15 meets the regulations starts at the design phase, placing function and reliability at the core of the device. Alongside this, we look at the use cases and requirements of our diverse audience and place them at the centre of our decision making.

Throughout the development process we also commission a number of reliability tests.

These include:

• Reliability testing
• Functionality testing
• Persona Testing
• User and Key Opinion Leader testing
• Water and dust ingress tests
• Vibration testing
• Drop testing from one metre on every face
• Button pressing and ports
• Environment chamber testing where we heat and cool the device to simulate exposure to warm and cold environments.
• Extended battery testing.
• Aging
• Electromagnetic Compatibility (EMC)

In passing these tests we can demonstrate the Grid Pad 15’s compliance with the legislation and give us the confidence knowing our devices will meet your needs.

We use internationally recognized standards for our quality (ISO 9001) and risk management (EN 14971), we also have traceability down to the component level from our entire supply chain (ISO 13485).

Useful links

Grid Pad 15 Declaration of Conformity

European Medicines Agency