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Home » Medical Device Single Audit Program (MDSAP) - Part 2

Medical Device Single Audit Program (MDSAP) - Part 2 (ELM-136)

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 2
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 ReviewsAccording to the Audit Model, the manufacturer must be able to map all processes, their links, and the ISO 13485 clause relating to them, and compare to the company processes and Standard Operating Procedures (SOPs), Quality Manual etc. This course will discuss this Audit Model further and the Best Industry Practices for organizing, training, and remediation of company processes and the quality management system.
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 2 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

Preparing for MDSAP Audit Process
Audit Criteria Built Into IMDRF Audit Model
The MDSAP Audit and Preparation
Manufacturers Guide to prepare for MDSAP
Where to Begin Preparation
Preparing for MDSAP: Ensuring Consistency
Sterile Medical Device Requirements
QMS: Deciding Which Processes Will Be Audited
How to Prepare for MDSAP Audit Areas
Preparing for MDSAP Audit: Training/Briefing
MDSAP and Management Review
Preparing for Audit: Gap Analysis
Documents to Prepare
Internal Audit-MDSAP Requirement
QMS Assessment Checklist: Benchmarking/Internal Audit
Internal Audits Plan Checklist
The Compliance Matrix: A Valuable Tool
Quality System Changes: ISO 13485:2016 and 21 CFR 820
Preparing for the MDSAP: Conclusion

The MDSAP Audit
What's Needed for Manufacturers Participation
MDSAP Audit: General Information
The 'Model Audit'? Document
MDSAP Audit Scheduling
Length of an MDSAP Audit
Timing for Answers During Audit
MDSAP Update on Audit Duration Adjustment
Sterile Medical Device Manufacturers: MDSAP
When are MDSAP Audits Conducted?
The MDSAP Audits
Stage 1: Initial Audit
Stage 2: Evaluation of QMS Implementation and Effectiveness
MDSAP : Surveillance Audit Timing
Stage 3: Recertification Audit
Audit Model: Special Audits and Short-Notice Audits
Special Audits and 'Recertification'? Terms
Audits Conducted by Regulatory Authorities
Unannounced Audits
Non-Conformities: MDSAP Grading
Non-Conformities and Interrelationship
The Audit and MDSAP Roles and Responsibilities


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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