about us

our expertise

Back in 2011, we identified apps as valuable tools within healthcare. Today this is more relevant than ever.

Our medical device, SSY Engine – a simulation tool for target intra ocular pressure, has in partnership with Abbvie Allergan, been released in over twenty markets all over the world.

Over the years, we have specialised in regulatory affairs for software as a medical device.

Careful Apps upholds an ISO 13485 certification.

we can

help you with

We assist the pharmaceutical industry in developing digital health tools to reach their end-users in sustainable ways.

We offer consultancy and courses on CE marking and regulatory for software as a medical device for the health tech industry.

HOW TO

develop a medical device?

You’ve got an idea.

You wish to create a software that either prevents, diagnoses or treats a disease or an injury.

It is regarded a medical device.

Where do you start?

  1. Idea
  2. Intended purpose – medical or not?
  3. Risk analysis
  4. Concept
  5. Technical development
  6. Validation
  7. Launch
  8. Maintenance and post market surveillance
CURIOUS

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