This highly interactive course draws upon real-life case studies as well as the expertise and experiences of instructors and guest speakers currently or previously working in the medical devices industry.
DurationStudents explore the innovative and rapidly expanding medical devices industry including roles and responsibilities from the Quality Assurance (QA) and Regulatory Affairs (RA) perspective.
This highly interactive course draws upon real-life case studies as well as the expertise and experiences of instructors and guest speakers currently or previously working in the medical devices industry.
Students learn how to interpret regulatory requirements and apply the key elements, processes, and best practices of a strategic risk-based QA/RA program required for timely regulatory clearance of safe and effective medical devices into Canada, USA and Europe markets.
Students discover the core elements of a robust Quality Management System (QMS), including processes such as document and record management, design control, risk management, internal auditing, supplier management, complaint handling amongst others.
Students learn to build effective communication and foster relationships to engage all stakeholders for QMS certification and regulatory compliance using international standards for medical devices (ISO 13485 and ISO 14971).
Students acquire the required knowledge and skills to work with Health Canada, the US Food and Drug Administration (FDA), and European Notified Bodies.
Why Sheridan?
Achieve Industry Standard Qualifications
Moreover, the MDRT course is instrumental in the healthcare system by training technicians who are paramount in ensuring that medical devices undergo proper decontamination and sterilization processes, thus mitigating the risk of infection transmission through surgical instruments and equipment.
This course introduces students to the key scientific principles and methods of disinfection and sterilization utilized in today's health care settings.
This course covers elements of decontamination, preparation, assembly, sterilization, storage and distribution of instruments and medical devices.
This certificate program prepares individuals to work in Medical Device Reprocessing Departments in hospitals and speciality surgical clinics.
By the end of the course, participants will have a comprehensive understanding of the regulatory requirements for medical devices, including Medical Device Classification and Quality Management, MDSAP, labelling requirements, and the application submission process.
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