Regulation (EU) 2024/1860 - Its impact on EU MDR and IVDR
How does the recent Regulation (EU) 2024/1860 amendment affect the EU MDR & IVDR?
Expert MDR & IVDR analysis
How does the recent Regulation (EU) 2024/1860 amendment affect the EU MDR & IVDR?
How to apply MDR pre-market clinical evidence requirements to medical devices intended for limited usage.
How do you define intended purpose, indication for use, intended clinical benefits, and claims?
Search the MDR and MDCG documents in seconds by asking EnableChat your questions.
We discuss the pros and cons of existing adverse event databases for vigilance data searching.
We explain what the SSCP is, when you'll need it and what its objectives are.
Justifying scientific validity is the first step in proving compliance with the IVDR.
Mantra Systems is going to MEDICA 2023, the largest medical trade fair in the world. We hope to see you there.
Understand what changes to your medical device are considered 'significant' under EU MDR (2017/745).
A guide to easily understanding whether your device is a medical device or an in vitro diagnostic medical device (IVD).
Will Great Britain continue to allow the use of the CE mark for medical devices beyond the 2024 deadline?
Find out how to build your own technical files within a guided framework while minimising financial outlays.
On January 6th 2023, the EU commission has adopted the proposal to extend the transition rules of the EU MDR.
We present a 7-step guide to navigating regulatory requirements on a budget.
We review recently updated requirements for UKCA marking and what it means for your regulatory strategy.
We've compiled a list of considerations that will help you make the right choice when choosing a CER writer.
We outline a strategy for the regulatory compliance of Class I medical devices.
We help to demystify the process of systematic search & review of literature for Clinical Evaluation.
We explain what you should know before beginning a literature search & 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.
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 MDR by one year.
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.