QM Consulting
We have been living our certified quality management system for years – and we pass this knowledge on.
Regulatory Compliance Without Detours
We are happy to advise you on the establishment, maintenance and further development of quality management systems in accordance with ISO 13485 and EU Medical Device Regulation 2017/745. Our consulting is not based on theory, but on what we practise every day.
From document creation to process design and audit preparation: we accompany you pragmatically – with the perspective of a manufacturing company that is subject to the same regulatory requirements as you.
ISO 13485 Setup & Introduction
Structured establishment of a certifiable QM system – from gap analysis to initial certification.
MDR Documentation
Creation and maintenance of technical documentation in accordance with EU MDR 2017/745 – practical and audit-proof.
Audit Preparation
Preparation for surveillance audits by notified bodies and for internal audit programmes.
CAPA & Risk Management
Introduction and optimisation of corrective and preventive actions, and risk management in accordance with ISO 14971.