Your partner for the entire medical technology product life cycle
Regulatory Affairs, Regulatory Certifications
Information
As a highly experienced development and production service provider, we at Solectrix understand that:
The path from the initial idea to an approved and successful medical device is a long one, accompanied by ups and downs. Regulatory requirements are not obstacles, but rather 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 you 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 outset (‘Quality by Design’)
Phase 2: Development & documentation – compliance in detail
Phase 3: Verification, validation & testing – objective proof
Phase 4: Production & supply chain – assured process quality
Knowledge transfer: training courses & workshops
We share our practical experience with you. In individual workshops and practical training courses on topics such as 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 producer.
Talk to us! Let's work together to make your project a success.
