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.
Live seminars
Our live seminars run periodically throughout the year and deliver live, expert training in all aspects of the MDR and its application to regulatory approval of your medical devices.
Seminars are tailored to specific groups and sets of medical device, ensuring that seminar content is maximally relevant to your requirements.
Due to the current coronavirus pandemic, our live seminars are set with provisional dates. Registration is open, but we are guided by advice from the UK Government. When restrictions are lifted enough for us to run them safely, we will email each delegate and ask them to confirm their place.
Available seminars
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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: 9th September 2020
- Delegate fee: £650 (includes lunch & refreshments)
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: 16th September 2020
- Delegate fee: £650 (includes lunch & refreshments)
More information about the MDR Compliance for Class I devices online workshop
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MDR Compliance for CEOs/CFOs
- A seminar 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: 23rd September 2020
- Delegate fee: £650 (includes lunch & refreshments)
More information about the MDR Compliance for CEOs/CFOs online workshop
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Clinical evaluation for Class III devices — do you have what it takes?
- An in-depth exploration of preparing towards and conducting clinical evaluation of Class III medical devices.
- Understand the impact of this risk classification on designing and implementing clinical evaluation activities.
- Date: 30th September 2020
- Delegate fee: £650 (includes lunch & refreshments)
Stay informed
Any questions?
If you have any questions about our MDR training, please get in touch.
- 0114 386 3349
- Email — contact@mantrasystems.co.uk
- @mantrasystems
- Unit 9 Fusion at Magna Business Centre Rotherham S60 1FE — Map
Download our free Mastering the MDR White Paper
MDR Services
Our team of medical doctors are specialists at building the clinical evidence portfolio that you need for MDR compliance of your products.
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Through our bespoke Post-Market Surveillance (PMS) service we will apply clinical knowledge to design, update, implement, and maintain your MDR compliant PMS systems.
- Designing your PMS system
- Vigilance systems
- Medical complaints
- Writing PMS plans & PSURs
- Clinical investigations & product registries
- Risk management
- Identify needs for any PACAs / FSCAs
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Our medical experts will design a robust and adaptable clinical evidence generation system to collect Post-Market Clinical Follow-up (PMCF) data on your medical devices.
- Design your PMCF strategy
- Build Medical Device Product Registries
- Ensure complete lifecycle evidence generation
- Prepare evidence reports for other departments
- Reduce time waste on administration
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Our full Clinical Evaluation service involves a 360-degree analysis of your medical devices, writing and reviewing CERs, and designing clinical development plans.
- Performing 360-degree Clinical Evaluations
- Write & review CERs
- Systematic literature appraisals
- Clinical evidence Gap Analyses
- Clinical development plans
- Designing & implementing clinical investigations
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Our medics will apply powerful clinical techniques to quickly and effectively identify and minimise any gaps in your clinical evidence portfolio.
- Identify your product's general SPRs
- Find gaps in existing evidence portfolio
- Systematic literature reviews
- Clinical development plans
- Impact analysis on Risk Management processes
EU MDR Compliance Guide
Our unique EU MDR Compliance Guide is written by our medical experts and is free to use. It covers all aspects of the new Medical Device Regulation. All guide topics
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Manufacturer's MDR responsibilities
How does the MDR define the broader responsibilities for manufacturers and what does this mean for the industry?
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Post-Market Clinical Follow-up Plan
How to plan your Medical Device Regulation (MDR) Post-Market Clinical Follow-up (PMCF) evidence generation strategy.
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Clinical Evaluation for the EU MDR
An introduction to Clinical Evaluation and the pivotal role it plays in medical device safety and performance under the EU MDR.
Latest updates
Keep up to date with our thoughts on the industry. All our articles
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Bridging the gap — ensuring that clinical investigations work in practice
How can medical device manufacturers ensure valid clinical investigations when access to medical expertise remains limited?
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Relaxing medical device regulatory requirements during a healthcare crisis
During the coronavirus pandemic, how far should we go when relaxing medical device regulatory requirements?