Medical Device 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.

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). 

Learners will plan, conduct, report and follow up on a QMS audit in accordance with ISO 13485:2016, MDSAP.

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.

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.

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.

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.

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.

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.

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.

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.

In preparation for an FDA inspection, it is important to familiarize yourself with the tools used by FDA investigators to conduct the inspection and to assess inspection outcomes to determine if further FDA action is necessary.

Marketing a medical device in a global environment offers many challenges, as regulatory requirements vary widely from one country to another.

NSF’s training courses give you tools to ensure your product complies with international standards and regulations. Our diverse training programs teach you how to implement and apply global guidelines through all stages of the product lifecycle.

Understanding the legal and regulatory framework for developing, marketing and distributing medical devices can be challenging.