Filter
6 items
Participants will gain a structured understanding of the regulatory frameworks governing medical devices and in-vitro diagnostic devices in the European Union. They will learn how device classification influences regulatory pathways and how to prepare technical documentation aligned with MDR and IVDR requirements. The program will also build knowledge of conformity assessment procedures, clinical evaluation expectations, and post-market surveillance obligations. By the end of the course, participants will be able to support regulatory strategy, ensure documentation readiness, and maintain compliance for devices entering or operating within the EU market.
Participants will gain a comprehensive understanding of the regulatory framework governing medical devices in Canada. They will learn how device classification determines regulatory pathways and how to prepare submissions for Medical Device Licenses. The program will also build knowledge of quality management system requirements, post-market surveillance responsibilities, and regulatory documentation expectations. By the end of the course, participants will be able to support successful regulatory submissions and maintain compliance with Health Canada requirements.
Participants will gain the ability to understand the European regulatory framework governing medical device commercialization and evaluate how regulations influence market access strategy. They will learn how to assess device classification, conformity assessment routes, and CE marking requirements when planning EU entry. The program will also strengthen the ability to analyze notified body engagement, clinical evidence expectations, and post-market compliance obligations. By the end of the program, participants will be able to develop a structured market access roadmap and make informed go-to-market decisions for medical device products.
Participants will gain the capability to interpret EU MDR requirements, design regulatory pathways for CE marking, prepare compliant technical documentation, and manage post-market obligations for medical devices in the European market.
Participants will gain the ability to establish quality controls for clinical investigations, evaluate study documentation for compliance, and support inspection readiness under ISO 14155 requirements.
Medical Device Process Validation Training
Participants will be able to understand regulatory expectations for medical device process validation, apply risk-based validation principles, execute IQ/OQ/PQ effectively, maintain validation documentation, and ensure ongoing process control in compliance with global regulatory standards.