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Friday, June 18, 2021
Home » Medical Device Single Audit Program (MDSAP) - Part 3

Medical Device Single Audit Program (MDSAP) - Part 3 (ELM-137)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~45 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 Device Single Audit Program (MDSAP) - Part 3
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 ReviewsThis course will examine the process of preparing and applying for the Medical Device Single Audit Program (MDSAP). It is written from the perspective of the Medical Device company that is considering joining or in the process of joining the program. In addition, an overview of the MDSAP program will be provided, as well as links to more in-depth information on certain topics.
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 Device Single Audit Program (MDSAP) - Part 3 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 Course?
Terms Explained
Course Modules

MDSAP Roles and Responsibilities During the Audit
Audit Tasks: Audit Model Used by Auditor
When Are Suppliers Involved in MDSAP?
Audit Organizations (AOs) and the Audit
Auditing Organization: Evaluation and Review
Auditing Organization Assessments: Regulatory Assessment
Regulatory Authority Assessor: Enforcement
Appeals to the Regulatory Authorities
Auditing Authority Complaints
Auditing Organizations: Accreditation
Who can become an MDSAP Auditor?
Cost and Training for MDSAP Audit Training
Roles: Regulatory
Roles: Consultancy Organizations
Collaboration with MDSAP Experts

Benefits and Future of MDSAP
MDSAP Success Based on Multiple Factors
Overall Benefits of MDSAP Implementation
Manufacturer Benefits of MDSAP Implementation
Advantages for MDSAP Participants
Benefits for Each Country Participant
Future of MDSAP
MDSAP Drawbacks
Challenges of MDSAP Participation
Combating Industry Fears
MDSAP Transition Plan Changes


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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