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Mantra Systems
United Kingdom
เข้าร่วมเมื่อ 14 ม.ค. 2020
Mantra Systems - We provide specialist EU MDR & UKCA Medical Device Regulatory Consulting Services.
We apply our medical expertise to the identification, analysis and production of clinical evidence, helping medical device manufacturers meet their obligations under the EU MDR and UKCA. Our unique approach to medical device regulatory consulting combines industry expertise with the key skills of clinically-active medical professionals.
Our core consulting services include:
- Clinical Evaluation with expert CER & CEP writing
- Systematic Literature Review data appraisal and analysis
- Clinical Evidence Generation through Post-Market Clinical Follow-Up (PMCF) Studies and Surveys
We also provide a selection of online EU MDR Training Courses, alongside downloadable EU MDR technical document templates and tools. These can be used with our regulatory compliant Document Management System, to give you an audit-ready solution for managing your own regulatory processes.
We apply our medical expertise to the identification, analysis and production of clinical evidence, helping medical device manufacturers meet their obligations under the EU MDR and UKCA. Our unique approach to medical device regulatory consulting combines industry expertise with the key skills of clinically-active medical professionals.
Our core consulting services include:
- Clinical Evaluation with expert CER & CEP writing
- Systematic Literature Review data appraisal and analysis
- Clinical Evidence Generation through Post-Market Clinical Follow-Up (PMCF) Studies and Surveys
We also provide a selection of online EU MDR Training Courses, alongside downloadable EU MDR technical document templates and tools. These can be used with our regulatory compliant Document Management System, to give you an audit-ready solution for managing your own regulatory processes.
Clinical Evaluation by Mantra Systems
Clinical Evaluation is a vital step in the medical device approval process. It's also a common failure point if not done to the required high standards, meaning delayed market access and greater expense to gain approval.
Mantra Systems are market-leading clinical evaluation service providers. To build on our 100% submission success record, we are now offering a 100% money back guarantee that and CEP & CER prepared by us will be approved by your Notified Body.
For more details, see our dedicated service page:
www.mantrasystems.co.uk/medical-device-regulatory-consulting-services/clinical-evaluation
Or contact our team for details:
contact@mantrasystems.com
Mantra Systems are market-leading clinical evaluation service providers. To build on our 100% submission success record, we are now offering a 100% money back guarantee that and CEP & CER prepared by us will be approved by your Notified Body.
For more details, see our dedicated service page:
www.mantrasystems.co.uk/medical-device-regulatory-consulting-services/clinical-evaluation
Or contact our team for details:
contact@mantrasystems.com
มุมมอง: 24
วีดีโอ
FDA vs MDR equivalence
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The FDA 510(k) route relies on 'substantial equivalence' to a device already on the US market. It's a desirable route as it can often avoid the need to generate new clinical evidence, saving time and money. The EU MDR also allows approval through equivalence - however, there are some key differences that can cause real problems for the unaware. In this short video, we highlight the key differen...
Your AI-powered MDR & MDCG chatbot
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A deep understanding of the MDR and associated MDCG documents is crucial for achieving compliance with the EU Medical Device Regulations. However, the MDR itself is 175 pages long and the MDCG documents, at the time of writing, number over 100 files. With so much information available it can sometimes be difficult to find the relevant information. To solve this problem we have developed EnableC...
EU/UK MDR Market Access Masterclass - December 2023
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Learn how to harness your clinical evidence for both medical device regulatory approval and marketing excellence. This webinar covers: 1. Clinical evidence reviews doubling as competitor analyses 2. Generate data and statistics for use in sales conversations 3. Produce evidence-based marketing material 4. Develop powerful tender applications supported by robust clinical data 5. Harmonise market...
CER Clinic - December 2023
มุมมอง 779 หลายเดือนก่อน
We ran one of our free CER Clinics in December 2023 where our followers can get direct access to our medical writing team and ask them any CER-related questions. Please note: The first question was not fully recorded at the start of the webinar. This question was: "I wanted to understand the main differences in writing a CER for a software product vs a hardware device. Are there any major thing...
MDR Annex II Templates - Produce MDR Annex II technical documents for your medical devices
มุมมอง 246ปีที่แล้ว
MDR Annex II is an important element of the MDR which sets out requirements for a range of technical documents that are mandatory when producing a technical document portfolio for your medical devices. The requirement set out in Annex II appear relatively simple but are broad in scope. In truth, many people only really come unstuck when they sit down to write the documents. Additionally, becaus...
MDR Risk Management training course - Build, document & maintain an ISO 14971:2019-compliant system
มุมมอง 123ปีที่แล้ว
Build an entire Risk Management system for all your medical devices. This training course is designed for people who want to produce complete Risk Management systems in-house. It is suitable for QA/RA professionals with existing knowledge of the EU MDR and company founders during early stage product development. The course will allow you to confidently build a complete Risk Management system fr...
Understanding the EU MDR training course - Gain clarity on your medial device regulatory strategy
มุมมอง 125ปีที่แล้ว
Build a foundation for your entire EU MDR system. We have designed this training course for people who are new to the EU MDR and who want to get started in building a regulatory strategy. Included is instant, on-demand and unlimited access to videos and downloads along with updates and additions to the existing training material. The training will allow you to take control of your regulatory st...
MDR CER Writing training course - Learn the secrets of our Clinical Evaluation process
มุมมอง 278ปีที่แล้ว
Implement a future-proof Clinical Evaluation process across your entire medical device portfolio. This training course is designed for QA/RA professionals who wish to produce MDR-compliant CERs in-house. It is also suitable for company founders and members of early stage start-ups. This Clinical Evaluation training course is presented by the CEO of Mantra Systems, Dr Paul Hercock, who has exten...
Clinical Evaluation Plan Template - Produce EU MDR-compliant CEPs for any class of medical device
มุมมอง 612ปีที่แล้ว
A Clinical Evaluation Plan (CEP), is one of the most important and most overlooked aspects of Clinical Evaluation under the Medical Device Regulation (MDR). It is much more than just a document. If done properly, a CEP lays down the foundations for a successful Clinical Evaluation process however, in most cases, most people are unsure how to construct and phrase a CEP and are not sure what sect...
MDReady Starter Guide - A free step-by-step guide for your journey to MDR compliance
มุมมอง 22ปีที่แล้ว
Welcome to MDReady, your free-to-download quick and easy starter guide to working with the EU MDR. Its objective is to help you understand key requirements and to build foundations for a successful MDR Compliance journey. It lets you see how Quality Management, Post-Market Surveillance, Risk Management and other aspects all integrate to produce a 'living', 'breathing' compliance system. It will...
Clinical Evaluation Report Template - Produce EU MDR-compliant CERs for any class of medical device
มุมมอง 683ปีที่แล้ว
As part of our EnableCE Build toolkit, our Clinical Evaluation Report Template will enable you to produce EU MDR-compliant CERs for your entire medical device portfolio. With 64 pages of expert guidance peer reviewed by medical professionals, it will give you full coverage of MDR CER requirements. 1. Apply the principles of our successful Clinical Evaluation process to your CERs 2. Build each s...
MDR Risk Management Templates - Build an adaptive & ISO 14971:2019-compliant Risk Management system
มุมมอง 146ปีที่แล้ว
Medical device Risk Management is a vitally important aspect of working with the MDR. It integrates and informs other parts of your regulatory framework. That said, it is not always done as well as it should be and alongside it being done poorly sometimes it is also incorrectly documented meaning that a reviewer is unable to determine that all aspects of Risk Management have been done in accord...
On-demand EU MDR Training Courses - EnableCE
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EU MDR Templates, Documents & Tools - EnableCE
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Welcome to EnableCE Build - the complete platform for putting knowledge into practice and putting together your MDR documentation. EnableCE Build takes the form of a range of document templates which are full of helpful guidance and explanatory notes, meaning there is no doubt at all when it comes to putting together these important technical documents. You are free to pick and choose exactly w...
An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER)
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An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER)
CER clinic - We answer all your Clinical Evaluation Report questions
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5 useful resources when writing a medical device Clinical Evaluation Report (CER)
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Five common pitfalls when writing a Clinical Evaluation Report
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Clinical Evaluation - Medical device CERs, CEPs, literature reviews & data analysis
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Clinical Evaluation - Medical device CERs, CEPs, literature reviews & data analysis
An in-depth look into medical device equivalence and its role in device approval under the MDR
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An in-depth look into medical device equivalence and its role in device approval under the MDR
Online medical affairs training courses & alternative, non-clinical career opportunities for doctors
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Online medical affairs training courses & alternative, non-clinical career opportunities for doctors
What is Post-Market Surveillance (PMS) in the EU MDR?
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What is Post-Market Surveillance (PMS) in the EU MDR?
Choosing the right Clinical Evaluation Report template
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Choosing the right Clinical Evaluation Report template
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How to build a winning strategy for EU MDR Compliance & Medical Device Regulatory requirements
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How to work with Annex VIII from the Medical Device Regulation (EU MDR)
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How to work with Annex VIII from the Medical Device Regulation (EU MDR)
How to work with Annex I from the Medical Device Regulation (EU MDR)
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How to work with Annex I from the Medical Device Regulation (EU MDR)
Profound thanks, Sir. Your presentations are Impeccable
@mantrasystems I don't know if you might be available for a brief call I'm reaching out to discuss an exciting business opportunity to enhance your Udemy course. The goal is to increase the visibility of your course, attract a broader audience, and cultivate positive reviews. I'll be looking forward to your response. Thanks
hi i'm medical device student i have to write a case study about Clinical Evaluation of Medical Device Technologies but i don't know how, i really need help.
Please read MEDDEV 2.7/1
Brilliant webinar! Exactly what I’ve been looking for! Thank you
Thanks for the overview
You're very welcome 😊
😻 𝕡𝕣𝕠𝕞𝕠𝕤𝕞
Thumbs up! Excellent slides and explanation.
Much appreciated! We are glad you found it rewarding.
Hi! thanks a lot, could you share me the pdf?
Hello Caro. The slides from our webinar can now be downloaded here: sowl.co/3cADv