Proven Quality Management System
For over 35 years we have been developing and manufacturing medical devices including active implants which require high quality and traceability. We have a proven QMS in place with thorough documentation which helps our customers ensuring compliance with the tight medical device regulations imposed by the FDA in the USA and by the European Commission with the Medical Device Regulation (MDR).
Ready for notified body and customer audits
The regulations on medical devices are getting tighter which means that legal manufacturers are required to have Quality Systems in place which often represents an increased level of supporting documentation required for certifications. It also implies suppliers involved in the design, manufacture, inspection or testing of the products. Legal Manufacturers must ensure that their most critical suppliers, i.e. those with the greatest impact on the conformity of finished devices, are fully compliant and prepared for unannounced audits. At Valtronic, we are fully prepared for notified body and customer audits and the documentation provided at any stage of a project are of tremendous support towards product conformity and certification.
Quality at any stage of your project
Our quality engineers are involved at any stage of a project, from design and development to industrialization and manufacturing. All of our sites are staffed with qualified quality engineers under the supervision of Directors of Quality who bring an average of 20 years’ experience in in renowned MedTech companies. Our quality team knows all the regulatory requirements and is used to and trained to FDA inspections as well as to 13485 and customer audits. We are ready at any time to help you meet regulatory requirement and thus optimize your time to market.