quality & regulatory assurance
When developing high-tech products and systems, it must be assured that they completely fulfil the customer’s requirements while fully complying with quality and safety regulations. In all our projects, this quality & regulatory assurance (QA/RA) is the project team’s responsibility across the board. Our QA/RA engineers are full-fledged, solution-oriented members of this team. Quality is an integral part of all project phases, from concept design and product development to production and product certification and registration. This makes us a true one-stop shop for new product introduction.
- feasibility studies, test house procedures, reliability studies, biocompatibility evaluations, clinical studies
- product certification and registration
- ISO 9001, ISO 13485, CE, MDR, IVDR, FDA approval
- V-model methodology and agile way of working
up to date.
In QA/RA matters, we have state-of-the-art technical knowledge of a wide variety of markets and are up to date with the relevant legislation. This ranges from the well-known CE for high-tech systems and MDR for medical devices, to the In Vitro Diagnostics Regulation (IVDR) and specific markets such as the regulations for drones. At the start of each project, we have a complete overview of the appropriate QA/RA requirements. In addition, we can quickly absorb new regulations, such as the IVDR. For international product registration, we make a business-oriented and risk-based selection of the countries for which the initial design is developed, taking into account mutual recognition agreements.
early risk mitigation.
Our development process is based on the well-known V-model for requirement verification and design validation. In each phase, we identify potential risks and take appropriate measures to mitigate them. Our agile way of working makes sure that potential problems are addressed early, to minimize the need for later redesigns. For each project – depending on the activities, i.e. development and/or production, and the nature of product, medical, high-tech or otherwise – we set up a tailor-made quality system.