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Friday, June 18, 2021
Home » Medical Device Single Audit Program (MDSAP) - Part 1

Medical Device Single Audit Program (MDSAP) - Part 1 (ELM-135)

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 1
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 1 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

Introduction to MDSAP
What is MDSAP?
International regulators: IMDRF
Parties involved in MDSAP and MDSAP pilot creation
International medical device regulators forum (IMDRF)
History of IMDRF
IMDRF and MDSAP requirements/documentation
The purpose of the MDSAP pilot
The MDSAP pilot timeline
The MDSAP timeline
MDSAP pilot program participating countries
International regulatory authorities participation
Observers of the MDSAP pilot and program
MDSAP - Roles of participants and observers
Pilot MDSAP 'Criteria for Success'?
How the MDSAP pilot audit was conducted
MDSAP pilot grading system
MDSAP Pilot: Mid-pilot status report
MDSAP Pilot: List of auditing organization participants
Expected improvements from implementing MDSAP pilot program audit model
Benefits of the 'All-in-One'? audit model
Manufacturers' benefits of participating in MDSAP pilot
MDSAP pilot goals and future MDSAP use
MDSAP pilot audit model online
FDA site specific online information/forms
MDSAP online policies, procedures, templates and forms
MDSAP FDA and ANSA question and answer site
MDSAP document for audit assessment

The MDSAP Audit Model Overview
MDSAP objective
About MDSAP objectives
MDSAP certificate
The MDSAP equals one audit for five countries
International participation and exclusions
MDSAP International and US participation
Manufacturers exceptions for inclusion in MDSAP: Electronic product radiation control
MDSAP audit plan has mapped requirements
MDSAP audit model structure
MDSAP Effectiveness: External factors
MDSAP impact on ISO 13485:2016
ISO 13485 versions
ISO 13485:2016 alignment with MDSAP
MDSAP audit general focus
The MDSAP audit-process approach
MDSAP Audit Roadmap: Seven process chapters
MDSAP sequence and interrelationships
Process Linkages (Interrelationships): audit model
MDSAP Audit Structure: Seven processes
Audit Model-FDA document P002 and companion document online


Final Assessment



Skill Level:

This training program has been developed to train employees with Basic 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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