Maven

Training

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Training

We understand the difficulties that come keeping updated with applicable regulatory requirements or interpret the requirements mentioned in standards and guidelines or even implementing and maintaining quality management systems. We understand because that is what we do every day of the week for you, your customers, and your bottom line.

Our course creators are subject matter experts who use real-life examples from their own experiences to bring each lesson to life.

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Training Excursion with Maven

We can build a training solution that matches the demands of your organisation by working directly with you and completely understanding your requirements, whether you’re training on existing standards, regulatory approval, or business improvement.We are one of the few certification organisations that provides a varied medical device training portfolio that includes specialised training sessions.

We provide a complete selection of medical device training courses in a number of forms, including online, public, or in-house if you would like to have a group of employees take a course together. Courses can be tailored to your specific needs.

CE marking training courses

  • Awareness on requirements of EU MDR (Medical Device Regulation) (EU)2017/745
  • Awareness on requirements of EU IVDR (EU) 2017/746.
  • MDD to MDR Transition Training.
  • Training on compliance to requirements imposed by Legacy devices.
  • Training on integrating the requirements of EU MDR in your existing QMS.

ISO 13485 training courses

  • Internal Auditor training as per ISO 13485:2016.
  • Awareness training on the requirement of ISO 13485:2016 and/or ISO9001:2015.
  • ISO 13485 and/or ISO 9001:2015 Implementation training.
  • Training on complying to the requirements of EU MDR with your existing ISO13485:2016.

Compliance training courses

  • Awareness on requirements of Risk Analysis as per EN ISO 14971:2012.
  • Awareness on requirements of Clinical Evaluation (MEDDEV 2.7.1 Rev. 4) andPMCF (MEDDEV 2.12/2 Rev. 2).
  • Awareness of Unique Device Identification (UDI) requirements.
  • Training on complying to the requirements of EU MDR with your existing ISO13485:2016.
  • Exclusive trainings for AMC clients:

    We have curated trainings for our Clients who have contracted with us their Annual Maintenance of their quality management system and regulatory certifications. The training courses have been devised keeping in mind the common challenges faced by medical device manufacturers in routine practices. The trainings include, but not limited to,

    • Importance of production as well as post-production activities in proving the clinical safety and performance of the device.
    • Importance of Practical CAPA Implementation of Previous Audit NCs?
    • PMCF forms – Strategies for collection, checking for the details
    • How to prepare for EU-MDR to reduce the timeline for getting certificate?
    • Areas to be focused during an IQA conducted for AMC clients. Thisincludes how to prepare an audit report, assisting the clients inpreparing the site for external audits. How to conduct IQA and MRM?
    • EUDAMED user account operation- this will cover managing user request, managing mandates, editing or changing PRRC, contact details etc.
    • Importance of Maintaining & Filling Change Note

These trainings are delivered in-person or online as required by the client. Training is arranged for a particular client if required with an adequate number of participants. Maven also organizes paid training sessions, which are open for participation for all medical device manufacturer across the globe. For details on our upcoming training, you can find the details on our Homepage or get in touch with us via email or WhatsApp.

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