Medical Technology Training Courses

This course will equip you with the tools and insights needed to articulate your vision, secure funding, and pave the way for Pharma 4.0 success.

Through this interactive session, participants will explore the forces driving the shift toward digital transformation, understand the challenges Digital CMC addresses, and learn about its operational and regulatory advantages.

This course explores how leveraging digital solutions, companies can not only accelerate the transfer of critical knowledge but also foster innovation and gain an edge in increasingly competitive markets.

Master the complexities of software classification under the Medical Device Regulations (MDR), ensuring compliance and clarity with expert insights into MDCG guidelines, practical case studies, and regulatory frameworks.

This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

This course provides an in-depth understanding of data governance for AI-enabled medical devices, focusing on European regulations like the AI Act and GDPR, ensuring compliance while fostering innovation in high-risk AI systems.

Gain essential knowledge in developing and managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW), focusing on regulatory compliance, risk management, and lifecycle management to ensure safety and effectiveness.

This course will help you understand future manufacturing of medical devices using 3D printing technology. Anyone from the medical device, additive manufacturing and pharmaceutical industries will benefit.

This session will guide participants through the key phases of digital health’s evolution, showcasing real-world cases that illuminate the challenges of  digital adoption.

This session will summarise the EU AI Act and its implications on the healthcare sector, including how to be compliant with the new regulatory framework.

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Learn the critical regulatory requirments and best practices for obtaining market authorisation or Software as a Medical Device (SaMD) and Medical Device Software (MDSW) in global markets.

This course provides essential guidance on navigating regulatory requirements and securing market authorization for AI-based medical devices, covering key regulations, compliance strategies, and best practices for global market access.

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

In this practical, one-day course, learn the regulatory requirements needed for successful post-market surveillance of medical devices and IVDs.

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives.