EU MDR Technical Documentation Training
Discover a practical approach to building, structuring and maintaining Technical Documentation according to Regulation (EU) 2017/745. Learn how Annex II and Annex III requirements connect device description, intended purpose, classification, GSPRs, risk management, verification and validation, clinical evaluation, labelling and post-market surveillance into consistent, traceable and assessment-ready Technical Documentation.
ISO 13485:2016 & Medical Device Quality Management Training
Discover a practical approach to understanding, implementing and maintaining a medical device Quality Management System according to ISO 13485:2016. Learn how QMS processes, responsibilities, procedures and records connect across the medical device lifecycle to support consistent implementation, product quality and regulatory compliance, including relevant interfaces with the EU MDR, EU IVDR and MDSAP.
ISO 13485:2016 Lead Auditor Training
Discover a practical approach to planning, conducting and leading Quality Management System audits according to ISO 13485:2016 and ISO 19011. Learn how audit planning, interviews, objective evidence, findings, nonconformities and reporting connect across the audit lifecycle to support effective auditing, audit team leadership and corrective action follow-up within medical device and IVD organizations.
Person Responsible for Regulatory Compliance Training
Discover a practical approach to understanding the role and responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under the EU MDR. Learn how PRRC qualifications, regulatory responsibilities, organizational positioning and interaction with the Quality Management System connect to support ongoing regulatory compliance throughout the medical device lifecycle.