Powerful medical device registries for Post-Market Clinical Follow-up (PMCF) designed by medical experts and driven by leading-edge eCRF, ePRO and data storage systems.
Find out more about our Post-Market Clinical Follow-up consulting service
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: 5th May 2021
- Delegate fee: £350 (exc. tax)
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: 12th May 2021
- Delegate fee: £350 (exc. tax)
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: 19th May 2021
- Delegate fee: £350 (exc. tax)
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: 26th May 2021
- Delegate fee: £350 (exc. tax)
More information about the MDR Compliance for Class I devices online workshop
MDR Consulting
Our team of MDR professionals are medical device regulatory consulting specialists offering tailored MDR compliance services.
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Market-leading Clinical Evaluation and CER-writing service delivered by MDR-trained medical professionals with extensive data assimilation and medical writing expertise.
Find out more about our Clinical Evaluation consulting service
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Complete Post-Market Surveillance (PMS) system design and implementation by medically-trained specialists. Comprehensive data collection, analysis and reporting for MDR compliance.
Find out more about our Post-Market Surveillance consulting service
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Comprehensive Gap Analysis service using advanced clinical techniques to identify and minimise any gaps in your clinical evidence portfolio, guiding your MDR transition strategy.
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We address the unique challenges of applying MDR requirements to medical software through special applications of our PMCF, PMS, Clinical Evaluation and Gap Analysis services.
Find out more about our Software as a Medical Device consulting service
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.
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Get exclusive free access to our MDR downloads written and compiled by our in-house medical specialists.
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Our unique EU MDR Compliance Guide covers all aspects of the new Medical Device Regulation and is free to use.
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Keep up to date with our medical team's insights and analysis on the latest medical device regulation news.
Latest updates
Keep up to date with our thoughts on the industry. All our articles
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Increasing data entry compliance in PMCF studies
5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.
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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.
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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.