The confinis Academy is a comprehensive e-learning platform tailored for the medical device industry. Designed to empower professionals and startups, our courses provide deep insights into regulatory and compliance challenges while preparing you for success in an ever-evolving industry.
Built and delivered by practicing experts, the confinis Academy translates complex regulatory frameworks into practical, real-world learning you can immediately apply in your projects. From FDA QMSR and ISO 13485 to EUDAMED, Swissdamed, UK registrations, AI in medical devices, and cybersecurity, each course is structured to help you build competence step by step—at your own pace, from anywhere.
The platform is ideal for startups, scale-ups, and established manufacturers who need flexible, on-demand training that fits busy schedules without sacrificing depth or quality. With self-paced modules, case-based examples, and access to exclusive consulting offers for learners, the confinis Academy supports continuous upskilling for regulatory, quality, clinical, and product teams looking to stay ahead of changing global requirements.
Learn the essentials of ISO 13485 compliance tailored for startups, including how to implement a quality management system that supports medical device development and regulatory approval.
Master regulatory data management for EU, Swiss, and UK markets. This course covers UDI registration, data exchange, and navigating region-specific database requirements to ensure compliance.
Explore the regulatory, ethical, and technical hurdles of incorporating AI into medical devices, including insights on FDA, MDR, and emerging global guidance for AI/ML technologies.
Understand key regulatory requirements and strategies to address cybersecurity threats, ensuring your medical devices remain secure and compliant with global standards like FDA and MDR.
Gain expert knowledge in implementing IEC 62304-compliant software lifecycle processes for medical devices. Available as a bundle with AI and cybersecurity courses for a comprehensive learning experience.
Learn the essentials of clinical evaluation for medical devices in this practical course. Understand EU MDR expectations, plan and document clinical evaluations effectively, and build a foundation for successful market access and compliance.
Master FDA Regulatory Pathways! Learn the essentials of 510(k), PMA, De Novo, and QMS compliance to streamline U.S. market entry. Gain insights into regulatory strategy, risk management, and submission best practices for a smooth approval process.
Learn to transition to FDA’s QMSR with ease! This course covers ISO 13485 alignment, risk-based practices, and compliance strategies to streamline processes, ensure regulatory success, and maintain a competitive edge in the U.S. medical device market
Let’s Shape the Future of Healthcare Together
Contact us today to better understand how confinis can help you.
