The Medical Device Trials in the EU: A Guide to the New EU MDR and Revised ISO 14155 (Device)- 3 hours

Frank Stein

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$549


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Background: 

This course will give an introduction into the European Medical Device Regulation EU MDR 2017/745 Annex XV CLINICAL INVESTIGATIONS and CHAPTER II DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION in conjunction with EN ISO 14155 with the requirements for clinical medical device trials. The introduction will give an overview about the term definitions, the generally requirements, the approval process with the authorities, conduction and reporting (to authorities) for clinical trials and an outlook with needs for the quality management system and the technical medical device documentation. An additional chapter will provide information for fast track approval in cases of devices related to COVID19 – Crisis.

 Why should you attend?

You should attend to learn more about the EU MDR 2017/745 EU MDR 2017/745 Annex XV CLINICAL INVESTIGATIONS and CHAPTER II DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION in conjunction with EN ISO 14155. The EU MDR is a complete game change to the old law of the MDD since 1993 and focus more on clinical data. For high risk medical devices and medical devices, who apply new technology. The time is very short and the number of requirements and required changes is high. Learn how to plan and conduct a clinical study under the new medical device law in Europe with the obligations for the sponsor, all other stakeholders, reporting obligations, serious adverse event reporting, how to work together during inspections by authorities and all required communication channels to stakeholders and authorities.  The introduction will give an overview about the term definitions, the generally requirements, the approval process with the authorities, conduction and reporting (to authorities) for clinical trials and an outlook with needs for the quality management system and the technical medical device documentation. An additional chapter will provide information for fast track approval in cases of devices related to COVID19 – Crisis.

 Description of the topic:

The EU MDR 2017/745 EU MDR 2017/745 Annex XV CLINICAL INVESTIGATIONS and CHAPTER II DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION in conjunction with EN ISO 14155 is  a new regulatory approach and need a  couple of adjustments in the clinical processes  and the medical affairs departments of the medical device manufacturer. The EU MDR is a complete game change in comparison with the old law and focus more on clinical data. For high risk medical devices and medical devices, who apply new technology. The new law requires more clinical data in the premarket phase and for conformity assessment and require more clinical data during post market surveillance. The need for clinical studies in the premarket phase for conformity assessment and the post-market-phase was huge expanded. Therefore  the clinical processes need to cover the life cycle of a medical device starting from the planning of the clinical activities in the premarket phase until the post-market-clinical-follow-up studies during the marketing of the medical device. The time is very short and the number of requirements and required changes is high. Learn how to plan and conduct a clinical study under the new medical device law in Europe with the obligations for the sponsor, all other stakeholders, reporting obligations, serious adverse event reporting, how to work together during inspections by authorities and all required communication channels to stakeholders and authorities.  The introduction will give an overview about the term definitions, the generally requirements, the approval process with the authorities, conduction and reporting (to authorities) for clinical trials and an outlook with needs for the quality management system and the technical medical device documentation. An additional chapter will provide information for fast track approval in cases of devices related to COVID19 – Crisis.

 

Areas Covered in the Session :

  • -          How to plan a clinical trial?
  • -          How to apply for a clinical trial at an competent authority?
  • -          How to document a clinical trial?
  • -          How to report SAE to a competent authority?
  • -          Benefit to work with a CRO?
  • -          Fast Track in the case of COVID19 related devices
  • -          Requirements for the quality management system
  • -          Requirements for the technical documentation

Who will benefit: 

  • -          CEO’s of medical device manufacturer
  • -          Clinical Affairs Manager of medical device manufacturer
  • -          Regulatory Affairs Manager of medical device manufacturer
  • -          Stakeholders of clinical studies

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Speaker: Frank Stein, Senior Expert Medical Devices

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.


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