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Home » Medical Dev: MDSAP Country Specific Requirements (Canada)

Medical Dev: MDSAP Country Specific Requirements (Canada) (ELM-142)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~60 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: Medical Dev: MDSAP Country Specific Requirements (Canada)
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsHealth Canada is the agency of the Canadian government that is responsible for national health policy and compliance, among other obligations. The agency has been a participating member of the MDSAP consortium working group, the International Medical Device Regulators Forum (IMDRF), in developing the MDSAP program. Canada's transition to MDSAP was initially announced in 2015, confirming the requirement for medical device manufacturers to transition from the Canadian Medical Devices Conformity Assessment System (CMDCAS) to MDSAP in order to continue to place devices within Canada.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Medical Dev: MDSAP Country Specific Requirements (Canada) course is included in the following Professional Certification Programs:

Medical Device Single Audit Program for Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more


Learning Objectives
Who Should Take This Program?
MDSAP Basics
MDSAP Audit Model
MDSAP and Canada (HC)

Chapter 1 - Process: Management
Auditing the Management Process
Audit Task 5

Chapter 2 - Process: Device Marketing Authorization and Facility Registration
Auditing the Device Marketing Authorization and Facility Registration Process
Audit Task 1
Audit Task 2
Audit Task 3

Chapter 3 - Process: Measurement, Analysis and Improvement
Auditing the Measurement, Analysis and Improvement Process
Audit Task 7
Audit Task 12

Chapter 4 - Process: Medical Device Adverse Events and Advisory Notices Reporting
Auditing the Medical Device Adverse Events and Advisory Notices Reporting Process
Audit Task 1
Audit Task 2

Chapter 5 - Process: Design and Development
Auditing the Design and Development Process
Audit Task 1
Audit Task 3
Audit Task 13

Chapter 6 - Process: Production and Service Controls
Auditing the Production and Service Controls Process
Audit Task 16
Audit Task 18
Audit Task 25


Final Assessment



Skill Level:

This training program has been developed to train employees with Intermediate Knowledge of Medical Device Single Audit Program (MDSAP).

Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

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For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

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