Mantra Systems
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.
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- 5 ай бұрын
Your AI-powered MDR & MDCG chatbot
- 23:21
- 7 ай бұрын
EU/UK MDR Market Access Masterclass - December 2023
- 28:33
- 7 ай бұрын
CER Clinic - December 2023
- 1:39
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MDR Annex II Templates - Produce MDR Annex II technical documents for your medical devices
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MDR Risk Management training course - Build, document & maintain an ISO 14971:2019-compliant ...
- 1:27
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Understanding the EU MDR training course - Gain clarity on your medial device regulatory strategy
- 2:43
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MDR CER Writing training course - Learn the secrets of our Clinical Evaluation process
- 1:50
- Жыл бұрын
Clinical Evaluation Plan Template - Produce EU MDR-compliant CEPs for any class of medical device
- 5:10
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Clinical Evaluation Report Template - Produce EU MDR-compliant CERs for any class of medical device
- 1:35
- Жыл бұрын
MDR Risk Management Templates - Build an adaptive & ISO 14971:2019-compliant Risk Management...
- 1:05
- Жыл бұрын
On-demand EU MDR Training Courses - EnableCE
- 0:51
- Жыл бұрын
EU MDR Templates, Documents & Tools - EnableCE
- 45:52
- Жыл бұрын
An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER)
- 5:51
- 2 жыл бұрын
What you need to know about the importance of medical device document management systems
- 7:53
- 2 жыл бұрын
An in-depth look into medical device equivalence and its role in device approval under the MDR
- 2:13
- 2 жыл бұрын
Online medical affairs training courses & alternative, non-clinical career opportunities for ...
- 2:59
- 2 жыл бұрын
What is Post-Market Surveillance (PMS) in the EU MDR?
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- 2 жыл бұрын
Choosing the right Clinical Evaluation Report template
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- 2 жыл бұрын
What is MDR Compliance?
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- 2 жыл бұрын
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