Your partner for the entire medical technology product life cycle
The path from the initial idea to an approved and successful medical product is a long one, accompanied by ups and downs. Regulatory requirements are not obstacles, but guidelines that ensure safety, quality and sustainability.
That is precisely why our Qualification & Verification (Q&V) department at our Mannheim site is more than just a consultant – it is your partner, combining the theory of standards with the daily practice of product development. Our expertise is not just theoretical, but has been developed in countless development projects. We offer practical, tried-and-tested support to bring your innovations to market safely, efficiently and sustainably.
Our holistic approach: quality from the idea to market surveillance
We accompany you through every phase and ensure that regulatory, normative and qualitative aspects are an integral part of your project from the very beginning.
Phase 1: Strategy & Concept – Quality from the start (‘Quality by Design’)
The greatest lever for success lies in the early stages. We help you set the right course from the very beginning to avoid costly and time-consuming redesigns and delays. This includes developing a viable approval strategy and establishing the central risk management process in accordance with ISO 14971, which runs like a thread through the entire project.
Phase 2: Development & Documentation – Compliance in Detail
We put the strategy into action. Our experts actively support you in creating robust technical documentation in accordance with MDR/IVDR. A particular focus is placed on usability (usability & human factors engineering according to IEC 62366), because a safe product must above all be safe to use. Since we develop in-house, we know how to create documentation efficiently, comprehensibly and in line with development.
Phase 3: Verification, Validation & Testing – Objective Proof
We provide proof 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 goal is not only to pass the tests, but to provide reliable proof of the quality of your product.
Phase 4: Production & Supply Chain – Assured 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). In addition, 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 courses & workshops
We share our practical experience with you. In individual workshops and practical training courses on topics such as the creation of technical documentation, risk management, MDR/IVDR or usability, we enable your team to build up regulatory expertise and anchor it sustainably in your own company.
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 with us! Let's work together to make your project a success.
