Obtain in depth knowledge about this new type of audit and how your organization is best prepared to support the completing of requirements within the allotted time.

Discover how this program differs from the traditional ISO 13485 through its regulatory audit approach, the grading of nonconformities, and handling of the audit report.

This course will prepare you to host a MDSAP audit and allow you to determine if your own internal QMS processes are consistent with the requirements of the MDSAP audit mode for the jurisdictions where your products are marketed.

Upon completion of this training, delegates will be able to support their organization to maintain compliance to ISO 13485 and jurisdiction requirements in the countries engaged in the MDSAP program.

Course Aim

Gain the knowledge and skills required to successfully host a MDSAP audit within your organization

How will I benefit?

This course will help you:

• Improve auditing skills focused on regulatory auditing
• Improve competence for MDSAP internal auditors and the support needed to host a MDSAP audit
• Assess your own audit models and suggest improvement
• Be prepared to support an efficient MDSAP audit by your selected Auditing Organization

What will I learn?

Upon completion of this training, delegates will have the

Knowledge to:

• Demonstrate awareness of MDSAP fundamentals
• Explain the structure and scope of the MDSAP audit program:
  • MDSAP audit processes and their interrelationships
  • MDSAP and organizational regulatory compliance
  • MDSAP reporting and nonconformity grading
• Explain the differences between MDSAP and other QMS audits
  • MDSAP and auditing in the medical device industry
  • ISO 13485 and ISO 14971
• Identify MDSAP documentation

Skills to:

• Prepare to host a sucessful MDSAP audit:
  • MDSAP 7 auditing process requirements
  • Plan audit scopes
  • Analyze data sources required during process audits
  • Analyze control interactions
  • Use correct jurisdictional terminology

Who should attend?

Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating territories and organizations expanding their market reach to jurisdictions participating in MDSAP.

Duration:

2 days

How will I learn?

Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites:

Delegates will benefit from reviewing the MDSAP Audit Approach Document and ISO 13485:2016 standard before attending this course.

Further Information:

Detailed course notes provided.

Related Training:

You may also be interested in attending our ISO 13485:2016 series of courses (including internal and lead auditing).

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

• Students need to connect to the class from any internet accessible location.
• Webcam and Microphone are REQUIRED.
• ALL course times shown are US EASTERN TIME.

If your class is In-person :

• You are encouraged to bring a laptop with you to class.
• Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.