mdauditor.com

WI-007: Cybersecurity Work Instruction

Course

This work instruction webinar bundle was updated to the 2025 FDA guidance and expanded to 25 pages. It provides detailed instructions and templates for compliance with the 2025 FDA Guidance on cybersecurity of device pre-market submissions.

SYS-044: Software Development and Validation Procedure

Course

This procedure is intended to meet the requirements of ISO 13485:2016, Clause 7.3.6 and 7.3.7 for design verification and design validation of medical device products, IEC 62304, ed. 1.1 and 21 CFR 820.30(a)(2)(i) and (g).

SYS-010: Risk Management Procedure

Course

This procedure is compliant with EN ISO 14971:2019. Includes templates for documentation of design, risk management, and process risk management.

SYS-004: Training Procedure

Course

This training procedure meets the requirements for ISO 13485:2016, Clause 6.2. Included with the procedure are templates for a training record, training matrix, new employee training checklist, and training webinar.

7 Steps to Responding to FDA 483 Inspection Observations

Course

Human Factors Training Series

Course

MDA's human factors training series includes all of our training webinars on human factors and usability engineering. This includes all of the templates needed to create a usability engineering file (UEF) as required by IEC 62366 and the FDA.