Medical Device Auditor Training
Today’s medical device auditor needs auditing skills, technical skills and up-to-date knowledge of the latest regulatory requirements. Meet these needs with NSF.
From our MDSAP-specific training and lead auditor course to our internal auditor training for many global regulatory requirements, we have you covered.
Instructor-Led Courses
EU IVDR Internal Auditor Training
This instructor-led two-day course provides guidance on how to prepare for, plan, and conduct an internal or supplier audit based on the EU IVDR.
EU MDR Internal Auditor Training
This instructor-led two-day course provides guidance on how to prepare for, plan, and conduct an internal or supplier audit based on the EU MDR. This course also focuses on ISO 13485:2016 relative to its correspondence with the EU MDR.
This course provides practical instruction for auditors and managers performing, facilitating, or managing internal and supplier audits against criteria contained within the European Union Medical Device Regulation (EU MDR).
CQI/IRCA-Certified QMS Lead Auditor Based on ISO 13485:2016 and MDSAP Requirements
Learners will plan, conduct, report and follow up on a QMS audit in accordance with ISO 13485:2016, MDSAP.
Internal Auditor Training Based on U.S. FDA 21 CFR Part 820
This 21 CFR internal auditor course is available as corporate in-house training and can be delivered in a format and time frame that works for you and your team.
MDSAP Internal Auditor Training
This virtual instructor-led course was designed and developed by the Medical Device Single Audit Program (MDSAP) Lead Project Manager responsible for the team that designed, implemented, and maintained the MDSAP program.
This training focuses internal auditors on the applicable MDSAP country-specific requirements that are applicable to the auditee organization.
ISO 19011:2018 - Applying Principles to Medical Device QMS Audits
This fast-paced instructor-led one-day course covers the basic concepts of planning, conducting, and reporting a medical device quality management system (QMS) audit in accordance with ISO 19011:2018.
Medical Device Single Audit Program (MDSAP)
This instructor-led one-day course covers the rationale for developing the Medical Device Single Audit Program (MDSAP), who the participating regulatory authorities are, and the specific audit criteria (including country-specific requirements) used during MDSAP audits.
Writing Effective Nonconformity Statements During Medical Device QMS Audits
This virtual instructor-led one-day course will introduce you to the importance of writing effective nonconformity statements during medical device manufacturer quality management systems audits.
This course covers the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements; and how to recognize when to communicate nonconformities during an audit; and identify tools and tips for writing effective nonconformity statements.
Online Self-Paced Courses
Medical Device Regulatory Requirements: Five-Course MDSAP Bundle
This 10-hour course bundle provides a comprehensive overview of the medical device regulatory requirements for all five countries currently participating in the MDSAP program, a requirement for all manufacturers utilizing audits.
MDSAP Overview and Country-Specific Medical Device Regulations: Six-Course Bundle
This six-course bundle provides an overview of the Medical Device Single Audit Program (MDSAP) and country-specific medical device regulatory requirements for the United States, Japan, Australia, Brazil and Canada.
Introduction to Writing Effective Nonconformity Statements During Medical Device Manufacturer QMS Audits
In this approximately 30-minute self-paced course, you will be introduced to the importance of writing effective nonconformity statements during audits of medical device manufacturer quality management systems.
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Interested in Corporate In-House Training?
Don’t see what your team needs? We can deliver a broad range of medical device auditor courses in a format that works for you and your team.
Get in touch