Quality and Regulatory Affairs

The Quality and Regulatory Affairs team at qtec services GmbH ensures that medical devices and IVDs meet stringent quality standards and regulatory requirements. They are responsible for quality management (including audits and QM systems), design control (covering clinical evaluations, requirements, risk management, validation, verification, and post-market surveillance), and obtaining international regulatory approvals. Their primary goal is to deliver safe, effective, and timely products to patients, staying flexible and qualified as a reliable partner to medical device manufacturers.