Your partner throughout the entire development cycle

Our holistic approach: Quality from concept to market surveillance

Phase 1: Strategy & Concept – Quality from the Start (“Quality by Design”)

The greatest opportunity for success lies in the early stages. We help you set the right course from the very start to avoid costly and time-consuming redesigns. This includes developing a robust regulatory strategy and establishing the central risk management process in accordance with ISO 14971, which runs through the entire project as a common thread.

Phase 2: Development & Documentation – Compliance in Detail

We put the strategy into practice. Our experts actively support you in creating robust technical documentation in accordance with the MDR/IVDR. We place particular emphasis on usability (usability and human factors engineering in accordance with IEC 62366), as a safe product must, above all, be safe to use. As we carry out development ourselves, we know how to create documentation that is efficient, traceable and integrated into the development process.

Phase 3: Verification, Validation & Testing – Objective Evidence

We provide evidence that your product meets the requirements – safely, reliably and reproducibly. We plan and manage all V&V activities, carry out computer software validation (CSV) and coordinate EMC testing (IEC 60601-1-2) with accredited laboratories. Our aim is not merely to pass the tests, but to provide robust proof of your product’s quality.

Phase 4: Production & Supply Chain – Guaranteed Process Quality

The quality of the product depends directly on the quality of its manufacture. We ensure this through systematic equipment qualification (IQ, OQ, PQ). Furthermore, we contribute our expertise as a production service provider and support you in the strategically important selection and qualification of your suppliers. In this way, we create a robust and compliant supply chain.

Knowledge Transfer: Training & Workshops

We share our practical experience with you. Through bespoke workshops and practical training sessions on topics such as the creation of technical documentation, risk management, MDR/IVDR or usability, we empower your team to build regulatory expertise and embed it sustainably within your organisation.

Solectrix Q & V is your integrated solution partner. We combine the strategic foresight of a consultant with the pragmatic implementation expertise of a developer and manufacturer.

Get in touch! Let’s work together to make your project a success.