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Targeted topics for
a deeper understanding
Our Deep Dives are intended to focus more closely
on the detail and nuance of more complex regulatory
topics.
Infused with practical examples and drawing from real-world
case studies, these courses allow us to share our expert knowledge
with you.
Value of Deep Dives
Some regulatory topics require an in-depth understanding before we can apply them to our devices. We’ve selected the topics we receive the most questions regarding, and have created detailed courses to examine both their principles and application in the real world.
These courses are written and presented by experts in global medical device regulations. We understand the most common pain points, knowledge gaps and challenges you face, and have written these courses with those in mind.
Join an active community of learners in an open forum, with access to regulatory professionals for all your specific questions and concerns.
Our Deep Dives
Clinical Evaluation Reports
Unlock the expertise needed to navigate the complexities of Clinical Evaluation Reports (CER) for medical devices under the EU MDR 2017/745 with this comprehensive course.
Dive deep into the regulatory requirements and gain practical, step-by-step guidance on how to develop and maintain CERs that meet EU standards and Notified Body expectations. Our course offers detailed insights and real-world examples, empowering you to confidently manage the clinical evaluation process from start to finish.
This course leverages the latest gudiance and feedback from real Notified Bodies, including insights from draft guidance not yet available to the general public.
Currently taking pre-enrollment. Launching November 2024.
Post-Market Surveillance (PMS)
Master the essentials of Post-Market Surveillance (PMS) for medical devices in both the EU and US markets with this tailored Deep Dive.
Learn how to implement effective PMS strategies that comply with MDR 2017/745 and FDA requirements, ensuring your devices remain safe and effective throughout their lifecycle. Through detailed lessons and practical examples, you will gain the skills to proactively monitor, analyze, and act on post-market data to maintain compliance and enhance device safety.
PMS is one topic we are asked most frequently about, and so have designed this course to tackle the most common questions, misconceptions and pitfalls that device manufacturers face.
Currently taking pre-enrollment. Launching December 2024.
Risk Management and ISO 14971
Risk Management is a cornerstone for medical device development and has become a key focus for global regulators when assessing device submission .
The Deep Dive is designed to help you effectively identify, evaluate, and control risks throughout the entire product lifecycle, ensuring compliance with international standards, in particualr ISO 14971. Our course offers practical insights, real-world scenarios, and detailed guidance to help you master the risk management process and integrate it seamlessly into your quality management system.
The principles of this course are applicable to many global markets, including both the EU and US, and will help you unlock market access around the world.
Currently taking pre-enrollment. Launching November 2024.
Quality Management and ISO 13485
Develop a deep understanding of Quality Management Systems (QMS) for medical devices with our specialized Deep Dive, with a focus on ISO 13485.
Gain the knowledge and skills needed to implement, maintain, and improve a QMS that meets international regulatory requirements and ensures consistent product quality. Through detailed lessons, practical examples, and expert guidance, you will learn how to navigate the complexities of ISO 13485 and drive continuous improvement in your organization.
The global effort to harmonize Quality Management requirements across international jurisidictions means this Deep Dive is more timely than ever, and has been created with a global outlook on QMS.
Currently taking pre-enrollment. Launching December 2024.
