How to build a winning strategy for EU MDR Compliance webinar

How to build a winning strategy for EU MDR Compliance webinar

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Free

How to build a winning strategy for EU MDR Compliance

About this event

This is not an online event as such, it is a pre-recorded webinar that you can access immediately, FOR FREE! Just view the video below:-

https://www.youtube.com/watch?v=tCVN95NoArI

Even though you do not need to purchase a ticket to watch the video - as it is free; we do recommend you click the 'purchase ticket' button as you will then qualify for 15 - 20% discounts for our products and services. IT WILL STILL REMAIN A FREE VIDEO FOR YOU.

ABOUT THE WEBINAR

Get beneath the skin of the EU MDR and understand the key requirements for medical device compliance. Build active regulatory systems that will safeguard your MDR transition through targeted knowledge and understanding. Learn the secrets to generating, identifying, appraising and analysing clinical evidence for medical device compliance. Access powerful resources and personal support that will complement your internal capabilities in working with the MDR.

Benefit from the unique knowledge and insight of our MDR-trained professionals. Aimed at suppliers and manufacturers of medical devices from across the industry, this webinar will give you an empowering perspective on working successfully with the MDR.

OFFERS:-

MDR Training Academy:-

A unique medical device regulatory support platform that will accelerate your EU MDR transition. Unlike any other service, our MDR Training Academy is designed to empower you and your team to build crucial regulatory systems and processes in-house, saving you time and money.

https://www.mantrasystems.co.uk/medical-device-regulatory-consulting-services/mdr-training-academy

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Clinical Evidence Generation:-

An effective PMCF (Post-Market Clinical Follow-up) system is essential for ongoing approval of most medical devices under the EU MDR.

  • PMCF study / survey design and implementation, fully compliant with EU MDR requirements.
  • GDPR-compliant data collection and secure storage using online eCRF & ePRO systems, enabling real-time data input from any device.
  • Lifetime monitoring of device usage with automated clinical data generation & reporting used for Clinical Evaluation and other areas of your MDR strategy.

https://www.mantrasystems.co.uk/medical-device-regulatory-consulting-services/clinical-evidence-generation

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Clinical Evaluation:-

An effective medical device Clinical Evaluation requires a detailed analysis of clinical evidence generated from multiple sources.

  • Clinical Evaluation Reports (CERs) & Clinical Evaluation Plans (CEPs) produced by MDR-trained medical writers.
  • Systematic literature reviews & data analysis forming the core of compliant Clinical Evaluation.
  • Ongoing Notified Body engagement support to address any queries and feedback after CER submission.
  • Adherence to MDR standards for all device classes according to MDR Annex XIV, MEDDEV & MDCG Guidelines.

https://www.mantrasystems.co.uk/medical-device-regulatory-consulting-services/clinical-evaluation

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Medical Writing:-

Writing technical documents for medical device regulatory compliance is a skilled task that requires a wide range of skills.

  • PMCF Plans, Study Protocols, Evaluation Reports, Investigator's Brochures, ICFs & PILs to support your PMCF system.
  • CERs & CEPs written by medical experts and comply with the latest guidelines & MDR Annex XIV Part A.
  • Expert clinical evidence & systematic literature reviews for Clinical Evaluation, Gap Analysis and market access activities.
  • Tailored technical documents meeting MDR requirements for specialist SaMD applications.

https://www.mantrasystems.co.uk/medical-device-regulatory-consulting-services/medical-writing

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Clinical Evaluation Report Templates:-

  • 57-pages of expert guidance
  • Full coverage of MDR CER requirements
  • Peer-reviewed by medical professionals
  • A lifetime of free revisions

Build each section by following instructions and answering questions using existing product information. Employ the rules to identify, appraise and analyse clinical evidence for developing and using search protocols. Use the specimen text to gain insight on wording, phrasing and emphasis.

https://www.mantrasystems.co.uk/medical-device-regulatory-guidance-resources/downloads/clinical-evaluation-report-template

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Gap Analyser Tool:-

  • Covers all MDR requirements
  • Point-by-point analysis
  • Enables efficient resource allocation
  • A lifetime of free revisions

Get granular analysis of requirements for PMS, PMCF, Vigilance, Risk Management & QMS. Go through the checklist of technical documents, plans, reports & files. Evaluate your GSPR conformity & analyse your clinical evidence.

https://www.mantrasystems.co.uk/medical-device-regulatory-guidance-resources/downloads/mdr-gap-analyser

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