quality systems

We provide complete support in global quality management system (QMS) consulting according to the client’s special business needs in the medical device and IVD industry. Services consider the international regulatory requirements of Europe, Australia, Canada, Japan, Korea, USA and others. Our services are beneath others…

• design and implementation of QMS acc. to ISO 13485, FDA QSR, CMDCAS
• document control systems
• design control systems
• CAPA program design and implementation
• PMS systems (post-market surveillance systems)
• compliance audits (internal, supplier, product, process and QSIT audits)
• sterilisation and process validation

We also offer a wide range of other services with regard to the EU Regulations MDR 2017-745 and IVDR 2017-746. Our staff has long-term and proven expertise in manufacture, regulatory affairs and quality assurance for companies working in the medical devices and in vitro diagnostics industry.