Clinical Investigations According to ISO-14155-2020 – Useful Methods for Effective Implementation
47 Min
1 Lesson
Price
$280 Per person
Lecturer
Danielle Giroud
MD-Clinicals SA, Switzerland
Founder, CEO of MD-Clinicals SA, Switzerland
With over 30 years of experience, Ms. Giroud is founder and senior faculty board member of the World Medical Device Organization (WMDO). Ms. Giroud is regarded as a recognized clinical research and regulatory expert within the medical device industry, having shared her extensive knowledge and experience with multi-national corporations and startup companies from around the globe.
She is also currently convener for the expert group on clinical investigations; TC 194 WG4 for the ISO 14155 as well as liaison with the EU Commission – CIE (Clinical Investigation and Evaluation) task force.
With over 30 years of experience, Ms. Giroud is founder and senior faculty board member of the World Medical Device Organization (WMDO). Ms. Giroud is regarded as a recognized clinical research and regulatory expert within the medical device industry, having shared her extensive knowledge and experience with multi-national corporations and startup companies from around the globe.
She is also currently convener for the expert group on clinical investigations; TC 194 WG4 for the ISO 14155 as well as liaison with the EU Commission – CIE (Clinical Investigation and Evaluation) task force.
Description
ISO 14155:2020 represents the state of the art guidance for medical device clinical investigations for human subjects. The document contains significant updates and is aligned with the latest regulatory requirements worldwide to ensure compliance in showing clinical evidence of a medical device and support patient safety and market access. The requirements of ISO 14155 apply to all clinical investigations pre-and post-market, which is now clarified further and provides extensive information on how to apply risk management throughout all activities of a clinical investigation. By attending this session you will not only learn what is new in ISO 14155, but also how to apply it in your quality system.
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