QARA Agile / Compliance agile

Clarify the regulatory status of your digital health solutions and accelerate their compliance

‍

We help your teams navigate regulatory requirements and turn compliance into a performance driver. By embedding quality into your product cycles, you increase agility, reduce timelines and accelerate market access.

Your main challenges

Identifying the regulatory status too late

Discovering late in the process that an innovative solution qualifies as a medical device can disrupt an entire product strategy. This ealization leads to rising costs, market delays and, in some cases, a full software redesign that compromises your development plans.

Compliance that feels out of reach

CE marking, FDA clearance, MDR, IVDR, ISO 13485, IEC 62304, the AI Act. The requirements are numerous, technical and demanding. For organisations not prepared for this level of complexity, the regulatory framework becomes a real barrier to bringing digital health products to market.

A Quality Management System that slows innovation

When poorly designed, the Quality Management System (QMS) becomes a constraint. It adds friction to processes, slows compliance, discourages product improvement cycles and consumes valuable time across teams.

Our approach

Clarify regulatory requirements from the start.

We run technical and regulatory workshops to assess your solution: status, class and applicable requirements. This early step removes uncertainty and builds a progressive compliance roadmap aligned with your market ambitions and product priorities.

Design a useful, agile and integrated Quality Management System

We create a tailored QMS that incorporates all relevant standards (ISO 13485, IEC 62304, ISO 14971) while fitting with your existing practices. Far from being a documentation burden, it becomes a living management tool that supports your innovation projects.

Embed compliance into product development

With Continuous Compliant Delivery, compliance is not left to the end. It is integrated into your development cycles. Regulatory evidence is generated continuously, with AI-assisted documentation ensuring an always up-to-date file and faster market releases.

Align compliance with product performance

Our expertise in digital medical device regulation, supported by our ISO 13485 certification, enables us to link regulatory requirements with business objectives. You reduce timelines, control costs and secure investments while staying compliant with European and US standards.