Home About Us
________________________________________________________________________________________________________

It all started with an observation...

During our assignments at Usarea, we observed that:

The structure of documents is often an impediment.

The standard is well known, but difficult to translate into clear deliverables.

Much time is wasted "reinventing" already proven frameworks.

Aptenys was created to make this process clearer, more accessible, and more effective

Good documentation facilitates good decisions

Compliance doesn't have to be opaque or stressful

Usability is above all a useful approach, serving users

Expertise forged in the field

The Aptenys platform was developed by Usarea, a consulting firm specialising in usability and human factors, which has been assisting medical device manufacturers in Europe and internationally for several years.

It was designed to help teams frame, document and manage their usability engineering process, in accordance with current regulatory requirements, while allowing the flexibility needed to adapt to each device and each context of use.

The templates offered on Aptenys are the result of...

Real Projects Carried Out for Medical Device Manufacturers (CE, MDR, IVDR, FDA)

Audit Defense Files

Over 10 years of experience with regulatory, quality, R&D, and clinical teams, across all classes of medical devices

Work carried out to meet the expectations of auditors and competent authorities

"Each template is designed to reflect the concrete expectations of authorities and auditors, while remaining pragmatic and directly usable."

Who is it for?

Aptenys is for all teams involved in the design and market launch of medical devices.

Medical device manufacturers

Quality, Regulatory, R&D, or UX teams

Structures geared towards efficiency and high standards

✓ For all levels

The templates are designed to be used by both experienced teams and more junior profiles, thanks to a guided and progressive logic.