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.
This course on Medical Device Regulation will provide participants with an in-depth understanding of the regulatory requirements for medical devices.
The course will cover Medical Device Classification and Quality Management, including Quality Management Systems (QMS) and the International Organization for Standardization (ISO) standards.
The course will start with an overview of the Medical Device Classification system, which is used to categorize medical devices based on their level of risk to patients and users.
Participants will learn about the different categories of medical devices, from Class I to Class III, and the regulatory requirements for each category.
Participants will learn about the structure of the applicable ISO standard, and how it relates to the development, manufacturing, and distribution of medical devices.
They will also gain an understanding of the requirements for implementing a QMS in accordance with the standard.
The course will then cover the Medical Device Single Audit Program (MDSAP), which is used by regulatory agencies in multiple regions to conduct audits of medical device manufacturers.
Participants will learn about the structure of the MDSAP audit, including the audit criteria and scoring system.
The course will also cover labelling requirements for medical devices, including the various types of labelling, such as product labelling, packaging labelling, and patient labelling.
Participants will also learn about the requirements for medical device submissions, including the Common Technical Document (CTD) format.
Learning Points:
Throughout the course, case studies and examples will be used to illustrate key concepts and provide practical insights.
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.
AAPS College is registered as a career college under the Ontario Career Colleges Act, 2005.If you are looking for a college that offers challenging programs in high demand fields, such as
AAPS is the place for you. Don’t wait for life’s rewards to come around – Make it happen by getting the education you need.
AAPS is the Canadian premier Life Sciences training college. The school was established in 2003 to address the growing demands for better prepared and more practically trained applicants.
In tailored response, AAPS was designed and made operational by a team of highly experienced industry experts with one mission in mind; to create professional skill development programs that would exceed industry-training standards”.
Employing only leading industry professionals with decades of experience, AAPS is setting the standard for pharmaceutical, food and healthcare, and Cannabis training and career advancement.
These experts continually develop and update the diploma and certificate programs and certificates courses at AAPS to meet the rigorous demands of the industry.
Two locations, Toronto and Mississauga and three state-of-the-art laboratories and modern classroom facilities, combined with ongoing partnerships and course development consultations with employers and regulatory bodies, have helped AAPS reach its unique and highly regarded place in the education and training field.
AAPS is among the top rated and most respected college in North America. The close industry relations, well equipped laboratories, and professional facilities allow AAPS to design and instruct programs that produce well-qualified graduates whom are eagerly recruited for professional employment at both entry and advanced levels.
AAPS graduates enjoy the highest employment rate in the industry. Come join us today!
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.
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.
A Medical Device Reprocessing (MDR) Technician is a medical professional who cleans, disinfects, sterilizes, prepares, and distributes instruments/equipment including endoscopes in a hospital or medical lab.
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