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.
Personalised support
Our personalised support offers the opportunity for you to embed one of our expert medical professionals into your company to provide tailored and personalised training to your regulatory team.
Our personalised support service will enable your specific MDR training needs to be addressed and will avoid the expense of working with external contractors to deliver MDR compliance services.
Limited by availability, we offer the opportunity to receive on-site training from medical professionals who are experts in applying their clinical knowledge to your MDR compliance needs.
Please contact us to discuss your requirements with our team:
- 0114 386 3349
- Email — contact@mantrasystems.co.uk
- @mantrasystems
- Unit 9 Fusion at Magna Business Centre Rotherham S60 1FE — Map
Alternatively, send us your details and we will call you back to discuss how our personalised support can help you.
Stay informed
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?