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.
Online workshops
Our range of exclusive online workshops are designed to facilitate learning without the expense of travel and accommodation.
Benefit from the clinical knowledge of our specially-trained medical professionals and learn how to integrate their expertise into your MDR compliance strategy.
Available workshops
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Build a winning MDR compliance strategy
- Date: 7th July 2020
- Delegate fee: £350
This is now fully subscribed. Please see our other available events.
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Software as a medical device — a guide to MDR compliance
- Date: 8th July 2020
- Delegate fee: £350
This is now fully subscribed. Please see our other available events.
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Build a winning MDR compliance strategy
- Understand the MDR in detail and become comfortable working with the MDR as a tool.
- Eliminate reliance on misleading and inaccurate secondary sources.
- Apply your understanding of the MDR to build strategies in Risk Management, PMS, PMCF, Vigilance, Gap Analysis and Clinical Evaluation that will drive MDR compliance of your company.
- Date: 4th August 2020
- Delegate fee: £350
More information about the Build a winning MDR compliance strategy online workshop
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Software as a medical device — a guide to MDR compliance
- 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: 5th August 2020
- Delegate fee: £350
More information about the Software as a medical device — a guide to MDR compliance online workshop
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?