Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness EN

The "Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness Training Course" is a two-day program designed to equip participants with the knowledge and skills necessary to effectively host an MDSAP audit within their organization. The course provides an in-depth understanding of this audit type and prepares organizations to meet the required standards within the designated timeframe.

Key Benefits:

• Enhanced Auditing Skills: Develop auditing skills with a focus on regulatory requirements.

• Improved Competence: Increase proficiency for internal auditors in supporting MDSAP audits.

• Audit Model Assessment: Evaluate and improve existing audit models.

• Audit Preparation: Get ready to facilitate an efficient MDSAP audit conducted by your chosen Auditing Organization.

Learning Outcomes:

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