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.
The instructors are industry-experienced in a supportive learning environment. Field-related internships give students real-world experience. Students also receive ongoing job search assistance and career services from AAPS.
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I am very happy that I chose AAPS as my next academic endeavor after graduating University. The course was very useful in teaching me the things that I will need to know when entering the Cannabis industry.
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Coming to AAPS to pursue my PG Diploma in CRDSP has been one of the best career decisions. I’ve received my offer letter to join as Project Management Associate at Axiom real-time metrics solutions, On.
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I was newcomer in Canada from Nepal. I enrolled in PG Diploma in Pharmaceutical QC/QA/RA course which i think was the best. After 3 weeks of hard work into co-op days, I was offered a full-time job.
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I am excited to share my employment news. I am now working as Quality Assurance Manager and I couldn’t have done it without your help and encouragement. I want to specifically thank all the AAPS instructors.
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