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.
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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.
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.
- PMS system design
- Vigilance systems
- Complaints handling
- PMS plan & PSUR writing
- Clinical investigations
- Risk management
- PACA / FSCA need identification
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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.
- PMCF strategy design
- Build Medical Device Registries
- Complete lifecycle evidence generation
- Evidence reports for other departments
- Reduce administration time
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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.
- 360-degree Clinical Evaluations
- CER writing / reviewing
- Literature appraisals
- Clinical evidence Gap Analysis
- Clinical development plans
- Clinical investigation design / implementation
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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.
- Genreal SPR identification
- Evidence portfolio gap analysis
- Literature reviews
- Clinical development plans
- Risk Management impact analysis
MDR Training
Our comprehensive training solutions are delivered by experts and address all aspects of MDR compliance.
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Our range of exclusive online workshops are designed to facilitate learning without the expense of travel and accommodation.
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Get expert training in all aspects of the MDR and its application to regulatory approval of your medical devices. Seminars can be tailored to specific groups.
Upcoming seminars:
- New events will be announced soon.
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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.
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Our range of White Papers, articles, documents and tools are free to download and contain a wealth of useful information on all aspects of MDR compliance.
- MDR Compliance Guide
- Articles from our experts
- Mastering the MDR White Paper
- PMS in the MDR White Paper
- MDR Requirements Matcher
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?