Biological Safety Evaluation ISO 10993 – Risk Approach – In Vivo – In Vitro Test – Technical File
– On Demand Live Webinar –
Duration: 50 min. + 10 min. Questions Time.
Fill the form below to schedule the live webinar on demand session:
ISO 10993-1:2009 describes:
This live webinar course will provide guidance on biological safety evaluation and ISO 10993:2009. In Particular will discuss the following points:
Why You Should Attend:
A medical device or material that comes in contact with the patient’s body is expected to perform its intended function without resulting in any adverse effect to a patient. Potential adverse effects can range from short-term (acute) to long-term (chronic) adverse effects to the body such as mutagenic effects. For this reason, medical devices are typically subject to biological evaluation and biocompatibility testing to assess the interaction between a device and tissue, cells or body fluids of the patient.
Biocompatibility testing answers two fundamental questions:
Who Will Benefit:
Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements.
Online Training Programs Includes:
Live Course Presented and Commented by:
Alice Ravizza is a Biomedical Engineer, graduated at Politecnico di Milano. She has great and extensive experience in R&D and QA / RA in the biomedical field. She is specialized in supporting Medical Device companies in building up and improve Quality System Management and assure Compliance through all the internal processs. She assist companies during the registration process for CE Mark making sure all the technical documentation is compliant to applicable standards and regulations. She is aswell an experienced Trainer and Lecturer.
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