quality systems 

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 / qualification and process validation / (sterilization, clean room management and hygienic monitoring) / compliance audits (internal, supplier, FDA Mock and QSIT audits) We are offering in our interim management program part-time functions of quality management representative, QA and QR, Safety Officer and Qualified Person. In all of these functions, we take responsibility of the correct implementation and maintenance of the applicable regulatory requirements. We also offer a wide range of other services with regard to the European medical devices directives AIMDD 90/385/EEC, MDD 93/42/EEC and IVDD 98/79/EC. Our staff has long-term and proven expertise in manufacture, regulatory affairs and qu