Regulatory Essentials in Health Tech: Biological and Electrical Safety
This on-demand session presents the core requirements for demonstrating biological and electromedical safety for medical devices. ISO 10993 series of standards are reviewed, from material characterization to biocompatibility testing. Likewise, the IEC 60601 and its application for determining electrical safety are presented.
The Regulatory Essentials in Health Tech training series consists of 14 1,5-2 hour on-demand webinar sessions. Read more on the complete course page here >>Jetzt registrieren
Regulatory Essentials in Health Tech: Biological and Electrical Safety
Inhalt
- Biological Safety
- MDR/IVDR perspective
- The ISO 10993 series of standards
- Biological Evaluation
- External service providers for testing
- Electrical Safety
- The IEC 60601 series of standards, scope and applicability
- Determining the right collateral and particular standards
- Essential performance and product classification
- Electromagnetic compatibility (EMC)
Trainer
”I have more than twenty years of experience in the Medical Device industry in various positions, with responsibilities for leading a quality assurance team and overall regulatory compliance according to the ISO 13485 standard, Brazilian (ANVISA), Australian (TGA), US FDA and the EU MDR requirements. I have also worked in the Management Representative role for various companies and most recently as a Person Responsible for Regulatory Compliance (PRRC).
My responsibilities have also spanned the design and development of new Medical Devices, their immaterial property rights (IPR) and supply management. I have worked in start-ups and growth companies for most of my career, holding also the role of a co-founder, which has provided me with a wide perspective into the challenges that young companies face on their way to the international market.”
Zielgruppe
All health tech developers and stakeholders interested in gaining specific knowledge on the electrical and biological safety requirements for the efficient commercialization of electromedical and other hardware medical devices. Special focus on start-up founders and staff, university innovator teams, as well as young health tech professionals and new employees.Nach diesem Training
- Know the basics for evaluating the biological safety of a medical device.
- Understand the relationship between different standards and standard families dictating the requirements for demonstrating the electrical safety of a medical device.
Hinweis
It is recommended to follow the Regulatory Essentials sessions 1-4 as well as sessions 8 (Risk Management) and 9 (Usability) before this on-demand session.What next?
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