Quality Management System

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Quality always prevails in the long run, and a robust Quality Management System (QMS) becomes an advantage rather than a burden when implemented correctly. We are dedicated in helping you optimize your resources, saving you time and money in the process. 

Standard for Quality Management Systems (QMS) in the medical device industry and the basis for most regulations like IVDR and MDR.

We offer a comprehensive range of services, including implementation, optimization, and QMS upgrades including CAPA - Root Cause Analysis, Process Validation.  

The new regulations for IVDs and Medical Device also require a robust QM-System to demonstrate compliance. 

We provide extensive experience in implementing QM-System requirements for IVDR & MDR. 

Medical Device Single Audit Programm is valid for USA, Japan, Canada, Australia and Brasil. 

We provide extensive experience in implementing MDSAP. 

We utilize an Integrated Management System approach to support the implementation of additional management systems within your existing systems.

We provide comprehensive support throughout the entire process, from application preparation to certificate issue, covering all aspects in between. 

We provide expertise in Risk management according to ISO 14971, helping you meet regulatory compliance requirements while improving processes and product safety. 

With experience auditing over 50 organizations from various perspectives (ISO 13485, MDSAP and IVDR) we provide a range of auditing services including Internal Audits, Supplier Audits and Mock Audits as well as support in Certifications & Notified Body Audit.