Quality Management in Medical Technology

We take the Pressure off with Development Support Services and thus Drive your Products Forward

We see ourselves as your reliable partner who not only recognises your needs, but also develops customised solutions – far beyond the development process. In the area of quality services, we endeavour to provide you with comprehensive support and streamline your work processes.

Our aim is to guarantee the highest quality throughout the entire product development of your medical devices. We support you in the creation of tried-and-tested documentation and establish robust processes that meet the regulatory requirements of medical technology. In doing so, we rely on proven standards to ensure the conformity and efficiency of your products.

Our Focus in Quality Management is on:

Implementation of quality management systems: We develop systems (in accordance with ISO 13485) that are customised to your company structure.
Documentation management: Our expertise includes the creation and maintenance of technical documentation, risk analyses and clinical evaluations to ensure the smooth approval of your products.
Process optimisation: We identify and eliminate weaknesses in existing processes to increase efficiency and compliance.
Audit preparation: We support you with internal and external audits, from preparation to follow-up.
Regulatory advice: We advise you on the approval of medical devices in accordance with ISO 13485, ISO 17025, ISO 10993, Meddev 2.71 rev4, EU 2017/745 (MDR), EU 2017/746 (IVDR), EU GMP guidelines, cGMP, Pharm.Eur., US.

We are also available to advise you on specific challenges and give you an honest assessment of our capabilities. Should you require additional support, please do not hesitate to contact us. Our commitment and expertise guarantee solutions that meet your requirements – precisely, sustainably and reliably.