1. Transition from FDA’s QSR to QMSR:
- Understand the transition from the FDA’s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR).
- Give yourself time to grasp the updated requirements and kickstart your organization’s transition.
2. Inspection and Audit Readiness Training for Medical Device Manufacturers:
Leverage decades of experience from our technical experts.
2. This experiential-based workshop equips teams to effectively prepare for external audits and inspections. 3. Hands-on exercises, best practices, role-play, and constructive feedback ensure readiness. Gain confidence in navigating challenges posed by FDA and Notified Body audits.
4. Medical Device QMS Overview Training:
- They are designed for both newcomers and experienced practitioners in the medical device field.
- Explore QMS requirements from the US FDA Quality Management System Regulation (QMSR) 21 CFR 820 and ISO 13485:2016.
- Understand the alignment and harmonization between QSR and ISO 13485. Discover opportunities to optimize performance beyond minimum requirements.
5. Internal Auditor Training:
Learn to plan and conduct internal quality management system audits. This includes:
- ISO 13485:2016
- Medical Device Regulation (2017/745), and IVDR (2017/746)
- Medical Device Single Audit Program (MDSAP) 
6. Understanding the Medical Device Software Development Life Cycle (SDLC) - IEC 62304:
In this course, you’ll explore aligning the Software Development Life Cycle (SDLC) phases, processes, and deliverables with US and global regulatory requirements. Specifically, we’ll focus on the critical interplay between SDLC and the IEC 62304 standard, which governs medical device software from design and development to manufacturing, distribution, and post-market surveillance.
- Gain insights into ensuring compliance and optimizing software safety and effectiveness.
7. Navigating Medical Device Cybersecurity Risk Management:
In this training, you’ll delve into the process of ensuring that cybersecurity risks in connected devices are identified and managed throughout the software life cycle. Key topics covered include:
- Regulations and Standards:
- Explore relevant regulations, standards, and guidance documents related to medical device cybersecurity. This includes insights from:
- IMDRF cybersecurity guidance
- MDCG cybersecurity guidance
- FDA premarket and postmarket guidance for cybersecurity
- ISO 80001-2
- ISO 14971
Interactive Workshops:
- Engage in class activities, including building a sample threat model.
- Incorporate principles such as cybersafety by design, information sharing, evidence capture, and incident response.

Remember, our training programs empower your team with essential knowledge and skills.