Two courses designed to support you with clinical strategy when conducting evaluations, investigations and PMCF Studies
Learn how to meet the latest regulatory requirements and collect the right type and amount of evidence. Explore the full clinical evaluation process, clinical investigations, and post-market clinical follow-up (PMCF). You’ll also review key clinical documents, including the CIP, CIR, CEP, CER, CDP, SSCP, and PMCF plans and reports.
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Register for a Free Training Session
The first module in the series is free to attend
Live & Recorded
What is Sufficient Clinical Evidence?
- Overview EU regulatory framework governing clinical evidence requirements for medical devices
- “Sufficient clinical evidence”, and what it means in practice
- The clinical evaluation process as described in the guidance – and how it works in real life!
- Evaluating and justifying the evidence based on product claims (implicit and explicit), risk, and intended purpose
Upcoming Medical Device Clinical Training Courses
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Clinical Evaluation for Medical Devices: MDR Compliance & CER Strategy
24 & 25 November 2026 | Hybrid Training | London
Original price was: £1,495.£1,095Current price is: £1,095.
Clinical Evidence Generation for Medical Devices: From Questions to Strategy
26 November 2026 | Hybrid Training | London
Original price was: £595.£476Current price is: £476.
Team Training Solutions
We support medical device leaders improve the technical skills and knowledge of their employees, so they are equipped to overcome challenges and meet business objectives. Working together, we design and deliver technical training courses that align with your learning requirements and business goals. For more information about how we can support your team please get in touch.
Could your medical device or IVD team benefit from any of the courses listed above? Or maybe a topic which is not highlighted? We would be happy to discuss your objectives and see how we might be able to help.
Register For Module 1 | Free
There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
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Free Medical Device Resources
We provide a wealth of free resources designed to elevate your career in medical devices. Delve into our exclusive free trainer interviews, thought-provoking articles, career advice and much more below.
Medical Devices & IVDs Free Module 1 Training Sessions
Free Module 1 Training for Medical Device & IVD Professionals
Many of our medical device and IVD training courses offer a free-to-attend Module 1, giving you valuable insights and a preview of the full course experience. Browse the available courses below and register using the form provided. Once registered, you'll receive joining instructions for the...
Essential Guide to Clinical Evidence for Medical Devices in the EU
Explore Key Standards and Guidance Documents
Introduction: The Role of Clinical Evidence in Medical Device Compliance In the European Union, gathering clinical evidence for medical devices is essential to regulatory compliance, particularly under the Medical Device Regulation (MDR). Clinical evidence helps demonstrate that a device is safe, performs as intended, and…
From 510(k) to PMA: Choosing the Right FDA Submission Pathway for Your Medical Device
Your step-by-step guide to the FDA’s 510(k), De Novo, and PMA submission routes.
Navigating the U.S. Food and Drug Administration (FDA) regulatory process can be one of the most challenging steps for medical device manufacturers aiming to enter the American market. Unlike the European system, where the CE marking process is guided by Notified Bodies under the Medical...
The EU AI Act and Medical Devices: What MedTech Companies Must Do Before August 2026
Understanding high-risk AI classification, data governance requirements and lifecycle compliance for AI-enabled medical devices in Europe.
Artificial intelligence is no longer a future-facing concept in medical technology — it is already embedded in diagnostic imaging, clinical decision support, digital pathology, wearable monitoring systems and predictive modelling tools. However, as AI capability has accelerated, so too has regulatory scrutiny. The introduction of...
What is UDI (Unique Device Identification)?
Learn More About UDI Labelling for Medical Devices
The Unique Device Identification (UDI) system is a globally recognised framework designed to provide a unique identifier for medical devices, enhancing traceability and safety within healthcare. It has become a cornerstone of regulatory efforts in both the United States and Europe, ensuring that medical devices,…
Comprehensive Guide to Chemical Characterisation and Biocompatibility in Medical Devices
Understand Chemical Characterisation to Ensure a Safe and Compliant Medical Device
In the medical device industry, ensuring safety and compliance with regulatory standards is paramount. Chemical characterisation and biocompatibility testing are essential steps in this process, guided by frameworks such as ISO 10993. These evaluations help manufacturers understand the materials in their devices and assess potential…
A Guide to Data Sources and Literature Review During ISO 10993 Biological Evaluation
Watch Educo Life Science Trainer Rona Middlemiss
We interviewed Educo Life Sciences trainer Rona Middlemiss to discuss Biological Evaluation literature review and data sources. This area is critical as it is a requirement of all medical device categories as per ISO 10993. It aims are to assess the risk and benefits of…
Understanding ISO 10993: Navigating Biological Safety for Medical Devices
Explore the Standards Aims and Challenges
ISO 10993 is the cornerstone standard for assessing the biological safety of medical devices. By focusing on risk assessment rather than prescriptive testing, it provides a flexible framework for evaluating device materials in their final form. This guide delves into the scope, challenges, updates, and…
Regulatory Affairs for Combination Products: Comprehensive Q&A
Q&A’s from the Free Module 1 Training Sessions
Combination products pose regulatory difficulties as the requirements of medical devices must merge with pharmaceuticals and biotech. As biotech and advanced therapeutics grows, so too does the need for specialised device delivery systems resulting in an increase in combination products. Similarly, device companies are increasingly...
Understanding ISO 13485: A Guide for Medical Device Professionals
Learn more about ISO 13485 and how to successfully implement it
ISO 13485 is a critical standard for companies involved in the design, development, and production of medical devices. It provides a framework for implementing a quality management system (QMS) specifically tailored for the unique regulatory requirements of this sector. In this article, we will delve…
Navigating the Regulatory Landscape for Combination Products in Pharmaceuticals and Medical Devices
Unlock the complexities of combination product development
Combination products, which integrate pharmaceutical and medical device components, are an innovative and expanding sector in medical solutions. This article, based on insights from expert Richard Young, covers the unique regulatory challenges faced by manufacturers and developers working with these products, especially in Europe and…
Medical Device Design & Development – Challenges When Transitioning Legacy Products
Interview with Educo Life Sciences expert Richard Young
Educo Life Sciences recently caught up with Richard Young to discuss legacy products and some of the most challenging aspects when transitioning them to comply with the new medical device regulations. The new European Medical Device Regulations means that legacy products need to meet new…
Can We Develop Products as Fast as the COVID Vaccines?
An Interview with Educo Life Sciences Trainer Nadine Ritter
We interviewed Educo Life Sciences trainer Nadine Ritter to find out why drugs cannot be developed as quick as the COVID vaccine. Nadine explains all the factors that led to the fastest development of a drug in history. Why Can’t We Develop Products as…
How Will The IVDR Impact You?
Interview with Educo Life Sciences trainer Richard Young
The In-Vitro Diagnostic Regulation (IVDR) was introduced by the EU to replace the In-Vitro Diagnostic Directive (IVDD). Under the Directive, most IVD products were self-certified. The IVDR is going to change all that with a new risk based classification system, many now need notified bodies…
A Quick Guide to Internal Audits for Medical Devices and IVDs
Interview with Educo Life Sciences trainer Richard Young
At Educo Life Sciences we have seen a recent increase in training requests/deliveries around internal audits for both devices and IVDs. As the regulatory landscape shifts to the MDR and IVDR, companies may be increasing their activities to demonstrate compliance. We interviewed our regulatory and…
A Short Guide to Human Factors in Medical Devices
Interview with Educo Life Sciences trainer Richard Young
The main aims of Human Factors Engineering (HFE) or usability are to create safe and effective medical devices and IVDs for human use. It is concerned with the design of devices that considers human capabilities, limitations, and characteristics. HFE in medical devices has become more…
How to get a Medical Device on the Market
Discover the Regulatory Roadmap to CE Marking
Bringing a medical device to market is a complex and multifaceted process that requires careful planning, extensive documentation, and adherence to stringent regulatory standards. In this guide, we will break down the essential steps for obtaining CE or UK CA marking, discuss the importance of…
What is Medical Device Product and Process Validation?
Watch a short video guide with Educo Life Science Trainer Richard Young
Product and process validation is critical process that must be done for regulatory compliance to ensure patients safety. Its main aim is to make certain the product is made correctly and consistently. We interviewed Educo Life Sciences trainer Richard Young to discuss product and process…
A Short Guide to Software as a Medical Device
Watch Educo Life Science trainer Richard Young discuss the biggest challenges and common mistakes
If you have a piece of software as part of your device you must be aware of the regulatory requirements in place to maintain patient safety. Whether it is an app that provides some additional features or specialised software that is critical to the…
A Comprehensive Guide to Medical Device Classification Under the MDR
From Class I to Class III Requirements with Examples
With the introduction of the new Medical Device Regulation (MDR) in Europe, the classification of medical devices has become more structured, emphasising the importance of patient safety at every risk level. From low-risk products in Class I to high-risk Class III devices, each category comes…
What is a PRRC (Person Responsible for Regulatory Compliance)?
Learn More about the Role of a PRRC
The Person Responsible for Regulatory Compliance (PRRC) is a pivotal role introduced by the European Union’s Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) under Article 15. As of 2017, all manufacturers, regardless of size, are required to appoint a PRRC to ensure…
Navigating a Career in Medical Device Regulatory Affairs
Insights from Educo Experts Anne Jury and Richard Young
We interviewed two of our trainers to get their views on a career in medical devices & IVDs, specifically regulatory affairs. They share their career experiences and provide some advice for those at different points in their device career. They discuss the many reasons...
Gathering Clinical Evidence for Medical Devices
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“I attended the full course and enjoyed the structured manner of teaching and the interactivity. We had a lot of interesting discussions during the course, which contributes a lot to my understanding and learning of the matter”
BAAT Medical