How to perform Gap Analysis on your own medical devices

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://youtu.be/-5rpkP99zHQ

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ABOUT THE VIDEO

Performing an MDR Gap Analysis is essential when transitioning a device’s regulatory framework from the out-going Medical Device Directive (MDD) to the new Medical Device Regulation (MDR) 2017/745. Undertaking an MDR Gap Analysis will enable the identification of any gaps in the clinical evidence portfolio, allowing measures to be taken to address these gaps before engaging a regulatory body.

Our MDR Gap Analyser tool will enable you to objectively evaluate your regulatory strategy against MDR requirements:-

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

We also have an EU MDR Compliance Guide that walks you through the entire Medical Device Regulation, including Gap Analysis:

https://www.mantrasystems.co.uk/eu-mdr-compliance/gap-analysis

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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