Live Webinar – Technical File Structure according to New Medical Device Regulation
Duration: 50 min. + 10 min. Questions Time.
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 methods of Unique Device Identification (UDI) and traceability of products for the CE marking and its main aspects as in the new EU Medical Device Regulations.
LEVEL: INTERMEDIATE (requires understanding of the current regulation)
Why You Should Attend:
On September 24, 2013, the United States Food and Drug Administration (FDA) released a final rule requiring that most medical devices distributed in the United States carry Unique Device Identifiers (UDI). FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. UDI implementation will improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.
According to the new Medical Device Regulation (MDR), with certain exceptions, a UDI will be required to appear on the label of a medical device and becomposed of two parts:
Device Identifier (DI) – a mandatory, fixed portion of a UDI that identifies the specific version or model of a device; and
Production Identifier(s) (PI) – a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device. This will be dependent upon the manufacturer’s internal quality system.
o the lot or batch number within which a device was manufactured;
o the serial number of a specific device;
o the expiration date of a specific device;
o the date a specific device was manufactured;
Who Will Benefit:
- Quality Manager
- Quality Engineers
- Design Quality
- Regulatory Affairs specialist
- Medical Affairs specialist
- Clinical Affair specialist
- R&D Engineers
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.