Medical device software regulation

Original to this reference.

Levels

1. Awareness

You can:

• explain that some health software is regulated as a medical device
• know who to ask when a product might be a medical device

2. Working

You can:

• follow a software life cycle process that meets medical device standards
• produce the records that such a process requires

3. Practitioner

You can:

• assess whether a product is a medical device, and its likely class
• plan the regulatory work for a product with quality and clinical colleagues

4. Expert

You can:

• set the organisation's approach to regulated software
• lead engagement with regulators and notified bodies

Closest ESCO skills

• ensure products meet regulatory requirements (broad match)

Contains ESCO v1.2.1 data (https://esco.ec.europa.eu/). © European Union. Reuse authorised under Commission Decision 2011/833/EU.

Role levels that expect this skill