How to achieve MDR Compliance for Class I medical devices
We outline a strategy for the regulatory compliance of Class I medical devices.
Expert analysis on medical device regulatory requirements
We outline a strategy for the regulatory compliance of Class I medical devices.
We help to demystify the process of systematic review of literature for Clinical Evaluation.
We explain what you should know before beginning a Systematic Literature Review for your medical device.
We outline five of the most useful and trustworthy Clinical Evaluation Report writing resources.
We illustrate five pitfalls when writing CERs and give you some tips to overcome them.
We'll show you what to keep in mind with regards to equivalance and Clinical Evaluation.
The 4 golden rules to drive regulatory compliance with PMCF and vigilance data collection.
The wider benefits of a well-designed PMCF system include improving your products and your relationship with your clients.
We tell you what to be aware of under the EU MDR regarding PMCF and your medical devices.
Watch our CEO, Dr Paul Hercock, deliver a Mantra Systems webinar on MDR compliance strategy.
Answer 10 quick questions to check whether your medical device requires a PMCF system.
How to ensure regulatory alignment of your devices in the territories affected by Brexit.
Getting ready for the MDR is a demanding process. Outsourcing might be your solution.
5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.
Our CEO Dr Paul Hercock was invited to speak on a Kaizen Life Sciences podcast about the challenges posed by the EU MDR.
Working with the MDR requires knowing how to work with clinical evidence. Medical doctors are perfectly positioned to meet this requirement.
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.
How can medical device manufacturers ensure valid clinical investigations when access to medical expertise remains limited?
During the coronavirus pandemic, how far should we go when relaxing medical device regulatory requirements?
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.
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?
Across the industry, medical device companies are facing challenges in meeting the demands of the new Medical Device Regulations (MDR) 2017/745 framework.
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.