FDA Presubmission Program – Requesting FDA Feedback

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 obligations
• Identify one strategy for conducting an internal audit against the EU MDR
• Plan 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

This virtual instructor-led two-day course covers the requirements of ISO 13485:2016, including the intent, meaning, and interrelationship of the ISO 13485:2016 clauses. This course will also introduce learners to ISO 13485:2016 Medical Devices – A Practical Guide. This guide was developed by ISO TC 210 (the developers of ISO 13485:2016) to assist medical device manufacturers in the practical application of the requirements of ISO 13485:2016 within a quality management system. Learners will demonstrate comprehension through individual and group activities throughout the course as well as a final course challenge.

This course pairs well as a prerequisite to Design Controls for Medical Devices and IVDs (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 key documents to help you understand ISO 13485:2016
• Recognize the primary elements of ISO 13485:2016
• Identify terms and definitions relative to the application of ISO 13485:2016
• Recognize similarities and differences between ISO 13485:2016 and the Quality System Regulation
• Demonstrate practical application of ISO 13485:2016 requirements through inspection scenarios

Price: $1200.00

This virtual instructor-led one-day course (delivered over 2 half days) 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 course discusses, in depth, the audit approach used by recognized MDSAP auditing organizations (AOs) as well as the MDSAP nonconformity grading system. Learners will also identify what MDSAP audit findings may trigger action from a participating regulatory authority.

This course pairs well as a prerequisite to 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:

• Discuss the Medical Device Single Audit Program (MDSAP)
• Evaluate the MDSAP Quality Management System (QMS) audit nonconformity grading system and recognize grades that may trigger regulatory follow-up
• Identify the IMDRF MDSAP requirements and documents in use
• Explain the MDSAP Audit Approach

Price: $800.00