Training in Risk Management in Medical Devices Standard 14971:2019 - 3rd edition
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Instituto Pedro Nunes (IPN) is promoting the 3rd edition of a training in Risk Management in Medical Devices - Standard 14971:2019, from October 19 to November 13, 2022. This training aims to elucidate the participants for the concept of risk assessment in Medical Devices, referring to the standard 14971, among other aspects.
Registration until 17th October here.
At the end of the formation the trainees should be capable of:
- Define the concepts of Risk, levels of Occurrence and Severity and Risk Assessment;
- Elucidate the basic aspects of the regulations adapted to Risk Management in DMs;
- Contextualise the essential requirements and harmonised standards of Risk Management;
- Define the mandatory procedures for Risk Analysis in DMs;
- Define the procedures for risk containment (contingency plan);
- Clarify the duties and rights of the MD manufacturer in the Risk Management process for MDs.
It is planned for 9 hours in synchronous sessions and 36 hours in asynchronous sessions, for a total of 45 hours of certified professional training (DGERT).
If two or more people from the same institution participate in the training, they will have a 10% discount.
More information formacao@ipn.pt
The training will be conducted by Sandra Balseiro, PhD candidate in Cellular and Molecular Biology, Master in Cellular Biology and graduated in Biology by the University of Coimbra. She has experience in the ISO 13485 standard since 2005, as Quality Manager and Technical Director, having been part of the first IVD company certified by the standard in Portugal (Genebox). Since 2007 she is Quality Auditor of the standards EN ISO 13485 and EN ISO 9001 and accessory standards of the DMs/IVDs, namely ISO 14971 and IEC 62366 and IEC 60601 and IEC 62304. Her teaching experience started in 2003 as Invited Professor at ESALD - Castelo Branco and ESTeSL - Lisbon (areas of Molecular Biology, Human Genetics, Molecular Genetics and Molecular Pathology). For about 10 years she has been a trainer and consultant in support of certification, having assisted in the certification process of various types of MDs/IVDs of multiple companies.
The IPN is a certifiedEntity by DGERT (Certificate 2376-2016). At the end of the action participants will be entitled to a Professional Training Certificate.
