Training
Risk management competence is not built in a single class.
At Let’s Talk Risk!, training is one part of a broader approach to helping professionals and teams build practical, lasting capability in medical device risk management. I use the word training because it is familiar. But the real goal is competence: the ability to think clearly, make better decisions, and apply ISO 14971 in the real world.
Most risk management training falls short in three ways. It is often too hard to access, too expensive to scale, and too disconnected from the ongoing practice needed to sustain competence. My goal is to offer a better alternative.
A different approach to risk management training
My training model, offered via our sister website ACHIEVE, is built around three principles:
Accessible
Learning should fit the reality of working professionals. That is why I offer a mix of on-demand courses, live workshops, and practical learning resources. This gives people the flexibility to learn at their own pace while still having opportunities for live engagement and discussion.
Affordable
Strong training should not be priced out of reach. Our programs are intentionally designed to be more accessible on cost than many traditional ISO 14971 offerings, making it easier for individuals and teams to build capability without a major budget barrier. Current public offers range from a $99 fundamentals course to $199 workshops and a $448 certification bundle.
Sustainable
Competence is built over time. The goal is not a one-time certificate and then silence. It is a progression: foundational learning, deeper ISO 14971 training, focused topic workshops, and ongoing reinforcement through Let’s Talk Risk! content and community.
How the learning pathway works
Here is the path I recommend for most learners:
Start with the fundamentals
Build a strong foundation in the language, logic, and structure of medical device risk management. The Risk Management Fundamentals Certification Course is designed for exactly that purpose to focus on 25 key terms and concepts used in applying
ISO 14971 requirements to medical device risk management.
Go deeper into ISO 14971
Once the foundation is in place, move into clause-by-clause ISO 14971 requirements and their practical application. The ISO 14971 Certification Bundle offers a higher value by combining the full ISO 14971 course with the fundamentals course, plus a coaching session after completion.
Strengthen specific skills through workshops
Targeted workshops help translate concepts into practice. Right now, you can attend an FMEA Workshop focused on linking FMEA to ISO 14971 risk assessments, and a Post-Market Surveillance Workshop covering requirements, data sources, signal detection, and risk file updates.
Keep learning over time
Sustained competence requires continued exposure to better thinking, better questions, and better examples. That is where Let’s Talk Risk! supports the journey through ongoing content, insights, and community learning.
Current training offers
You can explore the current training offers on the ACHIEVE website:
Full ISO 14971 Certification Course (USD $399)
ISO 14971 Certification Bundle (includes 1:1 coaching) (USD $448)
Live Post-Market Surveillance Workshop (USD $199)
Live FMEA Workshop (USD $199)
Proof that this approach is working
More than 200 certificates have already been issued, and the feedback continues to reinforce the value of a practical, structured, and accessible learning model.
See what others are saying about their learning experience.
Who this is for
This training is especially designed for both entry-level and experienced professionals in Quality, Regulatory, R&D, Medical Safety and Clinical Affairs.
Looking for team training or workshop
Group discounts and custom workshops are available for teams of 10 or more. Please contact us to discuss your special requirements.
