Simplifying the challenges posed by the new EU MDR
Our CEO Dr Paul Hercock was invited to speak on a Kaizen Life Sciences podcast about the challenges posed by the new EU MDR.
Online workshops
Our range of exclusive online workshops are designed to facilitate learning without the expense of travel and accommodation.
We offer a range of training events to familiarise stakeholders from across the industry to all aspects of the new MDR. Our events are targeted for:
- Product Specialists
- Regulatory Managers
- CEOs
- CFOs
- Anyone who wants to learn more about the new regulations
Available workshops
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MDR Compliance for CEOs/CFOs
- A workshop specifically geared towards senior company decision makers who require an overview of the MDR and what it means for their company.
- Delivered by a fellow company founder, this seminar focuses on business-critical aspects of MDR compliance that will ensure you maintain regulatory approval of your products after May 2021.
- Date: 11th November 2020
- Delegate fee: £350
More information about the MDR Compliance for CEOs/CFOs online workshop
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Software as a medical device
- Understand medical device legislation as it applies to software.
- Learn how to apply the MDR to software as a medical device.
- Understand how software features will impact product risk classification and requirements for conformity assessment.
- Build an MDR compliance strategy to ensure regulatory approval of your software product and protect your market position.
- Date: 18th November 2020
- Delegate fee: £350
More information about the Software as a medical device online workshop
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Clinical evidence in the MDR
- Develop a new level of confidence in applying clinical evidence to your MDR compliance strategy.
- Understand how to use clinical evidence in MDR Gap Analysis, PMS, PMCF and Clinical Evaluation.
- Understand aspects of clinical evidence interpretation that you always felt were beyond your grasp and feel confident in handling all types of clinical data.
- Develop a deep understanding of study power, study types, significance levels and other technical elements that will boost your competence in working with clinical evidence.
- Date: 25th November 2020
- Delegate fee: £350
More information about the Clinical evidence in the MDR online workshop
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MDR Compliance for Class I devices
- Understand the specific requirements for MDR compliance of Class I medical devices.
- Understand how requirements differ from those under MDD.
- Learn what to do to prepare your regulatory strategy for full implementation of the MDR.
- Date: 2nd December 2020
- Delegate fee: £350
More information about the MDR Compliance for Class I devices online workshop
MDR Consulting
Our team of medical doctors are specialists at building the clinical evidence portfolio that you need for MDR compliance of your products.
MDR Guidance
Our unique MDR guidance resources are written by our medical experts and free to use. They cover all aspects of the new Medical Device Regulation.
Latest updates
Keep up to date with our thoughts on the industry. All our articles
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Why medical doctors can drive MDR compliance
Working with the MDR requires knowing how to work with clinical evidence. Medical doctors are perfectly positioned to meet this requirement.
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Software as a medical device
Unless you have spent time working with medical device legislation in the past, the idea that software could be a medical device may be rather unexpected.