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Home » MDSAP: Medical Device Single Audit Program - Part 1 of 3

MDSAP: Medical Device Single Audit Program - Part 1 of 3

MDSAP: Medical Device Single Audit Program - Part 1 of 3 Certification Training
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Program/Course ID: ELM-135
Enrollment Period: 12 months.
Average Learning Time: ~45 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online, asynchronous, self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Medical Device Regulatory Affairs.
Demonstration: Five (5) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $199.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a training certification.

Training Program: MDSAP: Medical Device Single Audit Program - Part 1 of 3
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials 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 course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.


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).

MDSAP: Medical Device Single Audit Program - Part 1 of 3 is included in the following professional certification programs:

Training Program For Professionals:

Medical Device Single Audit Program (MDSAP) for Professionals

Course ID: MDSAP
Price: $1195.00.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relevancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.

Group Training for Employees: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.

Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Certificate of completion is instantly available once requirements have been fulfilled.
Verification of training:Certificates verifiable online with digital badges issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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