ASQ Certified Medical Device Auditor (CMDA) Knowledge Ref. Course MAR-2026

Fee structure:

ASQ Member and Non-members - $399

ASQ Unemployed Members - $200**

**NOTE: To get access to Unemployed Ticket option please contact:

Lead Instructor:

Upen Patel

E-mail: Upen_Patel@Edwards.com

Event Summary:

Auditing Fundamentals, Auditing and Inspection Processes, US Laws: QSR: CFR Title 21, U.S. requirements (FD&C Act), QSR, EU MDR, Health Canada, Other international agencies, International Standards, Validation, Risk Management, Restriction of Hazardous Substances (RoHS), Human factors and usability engineering, Biological evaluation, Packaging, Device Shelf Life, Controlled Environments and Utility Systems, Sterilization, Software Development and Maintenance, Quality Tools and Techniques, Process capability, Six Sigma, Lean Tools, Cost of Quality (COQ), Sampling.

Event Agenda:

Total Sessions: 10

When: Saturday, March 14, 2026, to May 23, 2026 Time: 8:30AM - 11:00AM (Pacific Time) Location: Live Webinar, California, USA Fee structure: $399 (member and non-members) and $200 for unemployed members

Class 1: Fundamentals of Auditing/Audit Planning

Date: Saturday, March 14, 2026, Time: 8:30AM to 11:00AM

Types of Audits, Audit Roles and Responsibilities, Ethical, Legal, and Professional Issues

Instructor: Upen Patel

Class 2: QSR/ U.S. Law Related to Medical Devices

Date: Saturday, Date: Saturday, March 21, 2026, Time: 8:30AM to 11:00AM, 2025

Regulatory Laws and Requirements, FDA - Code of Federal Regulations (CFR) Title 21,

Quality System Regulation (QSR) Requirements (21 CFR 820)

U.S. requirements (FD&C Act, 201, 301-304, 501-502, 510, 513, 518, 522, 704),

Instructor: TBD

Class 3: Audit Guidance: Performance, Reporting, Follow-up, and Closure

Date: Saturday, March 28, 2026, Time: 8:30AM to 11:00AM

Audit Preparation and Planning, Audit Performance, Audit Report, Audit Follow-Up and Closure, FDA’s Quality System Inspection Technique (QSIT), FDA CPG 7382.845

Instructor: Upen Patel

Class 4: European Regulation, Other International Regulation, Risk Management

Date: Saturday, Saturday, April 4, 2026, Time: 8:30AM to 11:00AM 05, 2025

EU MDR 2017/745, Health Canada, Other international agencies, Requirements for In Vitro Diagnostic (IVD) Devices, Post-Market Surveillance, Risk Management - ISO14971

Instructor: TBD

Class 5: RoHs Directives, REACH, Laboratory Testing and Failure Analysis

Date: Saturday, April 11, 2026, Time: 8:30AM to 11:00AM

Laboratory Testing and Failure Analysis, Safety and essential performance of medical electrical equipment (IEC 60601-1), Restriction of Hazardous Substances (RoHS) directive, Registration, Evaluation, Authorization, and

Restriction of Chemicals (REACH)

Instructor: Vinay Goyal

Class 6: Usability Engineering and Evolving Standards

Date: Saturday, April 18, 2026, Time: 8:30AM to 11:00AM

Human factors and usability engineering, General safety and performance

Requirements, Sources for New and Evolving Standards

Instructor: Bob Mehta

Class 7: International Standards, Validation

Date: Saturday, April 25, 2026, Time: 8:30AM to 11:00AM

International Standards (ISO 9001, ISO 17025, ISO 13485)

Validation IQ/OQ/PQ per GHTF/SG3/N99-10

Instructor: Upen Patel

Class 8: Sterilization/ Controlled Environment/ Packaging/ Biocompatibility

Date: Saturday, May 2, 2026, Time: 8:30AM to 11:00AM

Biological evaluation, Packaging, Device Shelf Life, Controlled Environments and Utility Systems, Sterile Medical Devices (Sterilization), Reprocessing/Reuse and Cleaning of Medical device, ISO 17665-1/2, ISO 11135-1/2, 11137-1/2, 11138-X, ISO 11737-1, 10993-1, EN 556-1, ISO 14644-1, 11607-1/-2, FDA Blue Book #G95, Federal Std 209E, US

Instructor: George Phillips

Class 9: Software Requirements in Medical Device, Other CFR (Labeling)

Date: Saturday, May 9, 2026, Time: 8:30AM to 11:00AM

Software Development (IEC 62366) and Software Maintenance , IEC 62304 (FDA Software Guidance),

Other CFR- Labeling (21 CFR 801, ISO 15223, 21 CFR 830)

Instructors: Karen Grams and Upen Patel

Time: 6PM to 9PM

Class 10: Quality Tools and Techniques, Process Improvements, Sampling

Date: Saturday, May 16, 2026, Time: 8:30AM to 11:00AM

Quality Control and Problem-Solving Tools, Process capability, Six Sigma, Lean Tools, Measurement system analysis (MSA), Cost of Quality (COQ), Qualitative and quantitative analysis, Attributes and variables data, Sampling

Instructors: Upen Patel