DURATION:

50 min + 10 min. Question Time

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Description:

The course is aimed at Quality Assurance personnel, Regulatory and Research and Development of biomedical companies, medical device manufacturers of any class, agents and distributors.

The course describes the structure and content of a technical file and its main attachments for the CE marking of a medical device.

LEVEL: INTERMEDIATE (requires understanding of the current regulation)

Why You Should Attend:

Technical File (TF) is required to obtain CE mark and normally contains the following information:

• General Information / Product Description / EC Authorized Representative
• Classification Determination (Annex IX, Rule)
• Essential Requirements (Annex I)
• Risk Analysis
• Labeling
• Product Specifications
• Design Control
• Clinical Evaluation (Annex X; literature review, et al.)
• System Test Reports
  —Functional Bench Testing
  —Lab Testing (cytotox, hemolysis, sensitization, carcinogenicity, other biocompatibility testing)
  —Sterilization validation (or AAMI TIR 28 Analysis)
• Packaging Qualifications
• Manufacturing
• Sterilization
• Conclusion
• Declaration of Conformity (Annex II, V, VII)
• Appendix (further supporting information / details on the above).

A clear undestanding of the structure and arrangement of Tech File documentation is required in order to fullfil the regulations and experience a smooth and fast commercialization of a new medical device.

Who Will Benefit:

• Quality Manager
• Quality Engineers
• Design Quality
• Regulatory Affairs specialist
• Medical Affairs specialist
• Clinical Affair specialist
• R&D Engineers
• Marketing

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.