Increasing data entry compliance in PMCF studies
5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.
Expert analysis on Medical Device Regulation
Keep up to date with our thoughts on the industry.
Latest articles
-
-
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.
-
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.
-
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.
-
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?
-
Relaxing medical device regulatory requirements during a healthcare crisis
During the coronavirus pandemic, how far should we go when relaxing medical device regulatory requirements?
-
A proposal to delay the EU MDR gets approved
A vote in the European Parliament has decisively approved a delay to full implementation of the EU's MDR by one year, allowing the medical device industry to prioritise its Covid-19 response efforts.
-
Out of the woods? EU regulators may delay MDR enforcement
A delay of the MDR would be welcome news for many, but what would a delay mean in practice? To what extent can preparations for EU MDR be put on ice?
-
The new MDR compliance challenge
Across the industry, medical device companies are facing challenges in meeting the demands of the new Medical Device Regulations (MDR) 2017/745 framework.
-
Sources of Real World Evidence for MDR compliance
At Mantra Systems our objective is to make sure that our clients choose the method of real world data harvesting that is right for them.
MDR Consulting
Our team of MDR professionals are medical device regulatory consulting specialists offering tailored MDR compliance services.
-
Powerful medical device registries and surveys for MDR 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
-
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
-
Market-leading Clinical Evaluation and CER-writing service delivered by highly-skilled professionals with extensive data assimilation and medical writing expertise.
Find out more about our Clinical Evaluation consulting service
-
Comprehensive Gap Analysis service using advanced clinical techniques to identify and minimise any gaps in your clinical evidence portfolio, guiding your MDR transition strategy.
-
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 Training
Our comprehensive training services are delivered by experts and address all aspects of MDR compliance.
-
Benefit from the clinical knowledge of our specially-trained medical professionals and learn how to integrate their expertise into your MDR compliance strategy.
-
Our range of exclusive online workshops are designed to facilitate learning without the expense of travel and accommodation.
-
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.
-
Embed one of our expert medical professionals into your company to provide tailored and personalised training to your team.
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.
-
Get exclusive free access to our MDR downloads written and compiled by our in-house medical specialists.
-
Our unique EU MDR Compliance Guide covers all aspects of the new Medical Device Regulation and is free to use.
-
Keep up to date with our medical team's insights and analysis on the latest medical device regulation news.