R&D with regulatory input from day one: innovate without rework.

We support your device's development with Design Controls from the concept stage, structuring the Design History File (DHF) and integrating risk management, usability and clinical evidence so the product is designed for registration - without regulatory rework at the end.

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R&D with regulatory input from day one: innovate without rework.
What we deliver

We join R&D early so regulation and engineering progress together.

  1. Design planning and controls under ISO 13485:2016.

  2. Design inputs and outputs, verification and validation.

  3. Integration of risk (ISO 14971), usability (IEC 62366) and evidence.

  4. Structuring the Design History File (DHF) and Device Master Record.

  5. Production transfer and a multi-market regulatory strategy.

Deliverables

What you receive

A development plan with Design Controls.
A structured Design History File (DHF).
A requirements → verification → validation traceability matrix.
An integrated regulatory roadmap (ANVISA, FDA, MDR).
References

Reference standards

  • ISO 13485:2016 - design and development controls.
  • FDA Design Controls (21 CFR 820.30 / QMSR) and MDR 2017/745.
  • ISO 14971, IEC 62366 and IEC 62304 integrated into design.
FAQ

Frequently asked questions

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Developing a device?

Bring regulatory affairs in from day one and avoid rework at registration.

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