Verification and Validation (V&V) for Medical Devices
Quality Assurance
Engineering & Validation
Starts at: 09:30
Duration: 2 Meetings
Language: Hebrew and English
This course is designed to give you the tools to make an informed decision regarding the testing and the ability to explain this decision in a manner acceptable to the regulatory authorities.
▪ Review the product verification and validation issue, from defining the issues to building a protocol, executing, and writing a report.
▪ How to read the right V&V standards and create V&V protocols that are applicable to specific devices, by understanding the standards terminology.
16.06.25
23.06.25
09:30-15:30
Haifa Matam
Price: 2,400 NIS + VAT
20% early registration discount until 29.05.25
About Ossie Milanov, B.A.
Ossie Milanov is a regulatory and quality expert. She has worked with many start up medical device companies over the years. She has experience in establishing, implementing and maintaining a QMS; in particular effective and compliant Risk Management and Post Market Surveillance. Ossie has experience in preparing Regulatory Strategies and submissions for the FDA, EU and WHO. She has successfully participated in...
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This course is designed to give you the tools to make an informed decision regarding the testing and explain this decision in a manner acceptable to the regulatory authorities.
▪ Review the product verification and validation issue, from defining the issues to building a protocol, executing, and writing a report.
▪ How to read the right V&V standards and create V&V protocols that apply to a specific device by understanding the standards terminology.
▪ What you need to consider when designing a sterile device, including a review of the different types of sterilization, the packaging requirements for sterilization, and the pros and cons of all the options.
▪ We will discuss how you define clean and disinfected. How do you validate a process that you do not control? A brief overview of the different processing methods used throughout the world.
▪ Determining what your packaging validation requirements are. How to build the protocol. What has to be addressed in a packaging validation?