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Duration: 50 min. + 10 min. Questions Time.

ON DEMAND

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Description:

ISO 10993-1:2009 describes:

• the general principles governing the biological evaluation of medical devices within a risk management process;
• the general categorization of devices based on the nature and duration of their contact with the body;
• the evaluation of existing relevant data from all sources;
• the identification of gaps in the available data set on the basis of a risk analysis;
• the identification of additional data sets necessary to analyse the biological safety of the medical device;
• the assessment of the biological safety of the medical device.

This live webinar course will provide guidance on biological safety evaluation and ISO 10993:2009. In Particular will discuss the following points:

1. ISO 10993:2009 Biological Safety Evaluation
2. Risk Approach
3. In Vitro Test
4. In Vivo Test
5. Biological Safety Evaluation and Technical File

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:

• Is the material safe?
• Does it have the necessary physical and mechanical properties for its proposed function?

Who Will Benefit:

• Manufacturing
• Quality Control
• Quality Manager
• Quality Engineer
• Regulatory Affairs specialist
• R&D Engineer
• Pharmaceutical Engineer
• Validation Engineer
• Process Engineer

Certification Requirements:

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:

• Answer to questions submitted during the webinar.
• An online final assessment with multiple choice questions.
• A Certificate of Completion.

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.

Promotion:

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