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PMS/PMCF of medical device

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  • Sarvesh
    06/09/2017 10:58
    Hi, I have recently started working in an Organization manufacturing medical devices. We manufacture devices for which predicate already exists (Generic devices). Now we are looking forward towards conducting PMCF study of those devices (e.g. Anterior Cervical System). How can we conduct our study in Europe, US and India to market our device i.e., How can we go for a multinational trial and what sorts of approval processes would be involved in India as well as foreign countries? Kindly help.
  • Operon Strategist
    05/09/2018 09:57
    Hello Sarvesh, Post Marketing Surveillance (PMS) is the practice of monitoring the safety of a medical device after it has been released on the market. Post-marketing surveillance guidelines is a collection of processes & activities used to monitor the safety & effectiveness of medical devices. The post-marketing surveillance includes the handling of the customer complaints, handling of the CAPA arising from the Customer complaints. We provide consultancy for PMS/ PMCF for medical devices globally. We have specifically catered clients in Europe, US and India. Visit our website for more information: https://www.operonstrategist.com and contact us for any further help.
  • Sunil
    11/03/2019 06:24
    First, of First, You have to be sure where you are going to market the device, in India, the US or Europe. accordingly, it will be decided you are obtaining Indian Licence, 510k or CE. I would suggest going one/one market, these PMCF studies required investments. start a pilot study and derive the result. with one study in India, with ICH-GCP & ISO 14155 you would be able to demonstrate the study in EU and USFDA. Next, you can always plan your big sample size studies.
  • Regulatory1
    16/03/2019 06:04
    It depends whether you want to conduct a clinical trial for regulatory approval or postmarketing surveillance. We are based in Bangalore and support for both clinical trial and PMS. reach us at info@regulatory1.in Our experts will review your requirement and suggest you accordingly, for free of cost. Further, you have an option to conduct the study.
  • i3c global
    01/10/2019 07:48
    If your plans sell medical devices in the EU, than clinical evaluation report (CER) is compulsory for businesses. More @ https://www.i3cglobal.com/clinical-evaluation-report.html
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