MEDICAL DEVICES AND APPLICABLE REGULATIONS (Buy Ticket Now)
Availability: Right Now (Recorded Presentation)
Duration: 70 min. (the average time to complete the training program).
Description: This webinar course will take you into the Medical Device Regulation field providing guideline, giving example and references to the applicable laws and standard.
An overview of discussed topic is here reported:
- What is a Medical Devices
- Definition and classification
- Main worldwide Regulations
- Notified Body
- Harmonization programs
- Risk control approach
- European Comunity Medical Devices directive
- Essential Requirement and Main Standards
- MDD Scope
- Method of assessing compliance to MDD
- Manufacturer definition, obbligations and responsability
- Device classification and CE Mark path
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.
Why Should You Attend:
Continuing education and professional development are critical to the regulatory professional. Regulatory professionals must keep up to date with regulatory policies and procedures for one or more countries, as well as maintain an understanding of the scientific and technical background of healthcare products. A clear understanding of regulatory process and applicable regulation is necessary for creating technical documentation, maintain up to date existing one and assure compliance. This webinar course will provide a comprehensive overview and guidance to the Medical Device regulation.
Who Will Benefit:
- Regulatory Affairs specialis
- Medical Affairs specialist
- Clinical Affair specialist
- R&D Engineer
- Quality Engineers
Online Training Programs Includes:
- 90 days of 24/7 access to individual eLearning courses.
- Answer to questions submitted during the webinar.
- An online final assessment with multiple choice questions.
- A Certificate of Completion.
Course Presented and Commented by: Ing. A. Ravizza
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.