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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).  The instructor will review the regulation in depth from the auditor’s perspective and provide practical instruction for preparing for, planning, and conducting EU MDR audits according to NSF’s formal, documented EU MDR Audit Model. This course includes a two-hour eLearning prerequisite module, EU MDR – A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers every aspect of the regulation and identifies key pre- and post-market requirements associated with EU MDR – standard regulatory requirements that must be met by all medical device manufacturers wishing to do business in the EU regardless of device classification. Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.By the end of this training you should be able to: Recognize the primary elements of the European Medical Devices Regulation 2017/745 (EU MDR)Recognize specific requirements relative to manufacturer obligationsIdentify one strategy for conducting an internal audit against the EU MDRPlan a manufacturer audit against EU MDR Who should attend:This course is helpful for experienced internal auditors seeking to expand their auditing knowledge of the EU MDR, for managers of audit programs, and for anyone who will be the subject or participate in an EU MDR audit. Learners should have some internal audit experience and ideally have certified auditor/lead auditor qualifications in QMS audits.Price: $1200.00
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 and EU MDR requirements.
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. This focus, when used in conjunction with an existing ISO 13485 internal audit program, will provide the comprehensive coverage necessary to assure all applicable MDSAP regulatory requirements are audited. In addition, resources and insight into how MDSAP Auditing Organizations establish competence of their auditors will be discussed. An “MDSAP Lite” audit tool will be provided including country-specific requirements and hyperlinks to the specific regulatory requirements (audit criteria) relative to each country-specific requirement. Through expertly designed individual and group tasks and activities, learners will demonstrate how to identify applicable country-specific requirements, how to plan the time necessary to conduct the audit of applicable country-specific requirements, how to plan an MDSAP Lite audit, as well as how to identity, document, and grade country-specific nonconformities. This training is essential to anyone engaged in planning or conducting internal audits of an organization participating in MDSAP.Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.By the end of this training you should be able to: Describe an MDSAP Audit and identify criteria used during an MDSAP AuditRecognize International Medical Device Regulators Forum (IMDRF) governing procedures relative to MDSAP Auditing OrganizationsRecognize the competency and training requirements for AO auditorsRecognize the structure and utility of the “MDSAP Lite” internal audit approach and “Toolkit”Calculate audit time and plan an MDSAP Lite internal auditIdentify nonconformities, write nonconformity (NC) statements, and support the nonconformity statements with audit evidenceIdentify post-audit MDSAP activities including NC gradingRecognize the outcomes and goals of an MDSAP auditPrice: $1200.00
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.In addition, learners will apply the concepts covered during the course through practical application. Working in groups, learners will review multiple nonconformity scenarios, develop nonconformity statements relative to the scenarios and participate in instructor-led analysis of the nonconformity statements. This course pairs well with CQI IRCA-certified QMS Lead Auditor based on ISO 13485 2016 and MDSAP Requirements, EU MDR Internal Auditor (2 day), EU IVDR Internal Auditor (2 day), and MDSAP Internal Auditor Training (2 day). Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.By the end of this training you should be able to:Identify useful techniques to apply when writing effective nonconformity statementsReview fundamental terminology important to writing effective nonconformity statements including audit, objective evidence, audit criteria, and nonconformityEvaluate the use of the acronym FOCAL as a tool for developing an effective nonconformity statement.Apply the three key principles when writing a nonconformity statementPrice: $800.00

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