Quality management
Our services for your company
Quality management
MDSS Consulting GmbH provides you with expert support in designing, documenting and maintaining a functioning quality management system (QMS) – individually tailored to your company and product requirements. Our goal is a practical QMS that supports your employees in their daily work and complies with all regulatory requirements.
Our services at a glance
- Development and implementation of customized QMS structures to comply with EN ISO 13485
- Support in complying with the QM requirements of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)
- Strategies for manufacturers of class I medical devices or class A in-vitro diagnostics to implement a QMS in accordance with MDR or IVDR
- Integration of additional regulatory requirements such as GMP, FDA, MDSAP or other country-specific requirements
- Reduction of audit risks:
- Implementation or support of internal audits and/or supplier audits
- Preparation and support for external audits by notified bodies, authorities or customers
- Support in the handling of audit deviations
Our Goal
You can rely on our experience when it comes to setting up or developing your quality management system effectively and in a legally compliant manner.
Our goal: A QMS that complies with regulations, fits your products and supports your employees in their day-to-day work – clear, practical and compliant.
MDSS Consulting GmbH – Your bridge between regulatory requirements and business practice
Would you like to find out more or do you already have a specific project in mind?
Then we look forward to hearing from you and working with you to find the right path for your QMS. You are welcome to take advantage of our free initial consultation*.