Services

Support on QMS, Assessment on compliance with Regulatory requirements and on Technical Documentation for IVD and Medical Devices organizations

Internal Audits and Supplier Audits for IVD/Medical Devices and Testing Labs

Third-Party Audits for Notified Bodies, Certification and Accreditation Bodies, and Auditing Organizations

Training on Regulatory requirements and Standards, such as, IVDR, MDR, ISO 13485, ISO 14971, MDSAP