CMDA case studies

CMDA · Put your knowledge to work in context.

The Certified Medical Device Auditor (CMDA) is a professional certification for people who audit quality management systems in the medical device industry - internal auditors, supplier and second-party auditors, quality and regulatory affairs specialists, consultants, and auditors working for certification or regulatory bodies. It signals that the holder can plan, conduct, report, and close out an audit against medical device requirements, not just recite clauses. The CMDA case studies are 5 cases and about 4,975 words.

The Sterilization Auditor Who Owns the Sterilization Process

NovaThera (380 employees) contract-manufactures Class II electrosurgical generators and performs in-house EO sterilization plus sterile barrier packaging. The annual internal audit programme covers 14 processes; sterilization and sterile packaging are audited every year.

892 words, about 4 min 2

Defending a Sample When 78% of Complaints Are Closed Without Investigation

MediFlow manufactures infusion pumps on three product lines. You are lead auditor for a 4-day on-site audit of complaint handling and CAPA, accompanied by one trainee.

984 words, about 5 min 3

Eight Pieces, an Outdated Form, and a Verbal Agreement

You are auditing incoming inspection at a device assembler. Work instruction WI-114 rev C specifies AQL 0.65, general inspection level II.

1,011 words, about 5 min 4

The Repeat Nonconformity: Retraining That Did Not Work

Eleven months ago, a major nonconformity (CAPA-118) was raised because the leak test was not performed on three lots of catheter balloons. The recorded root cause was "operator error"; the corrective action was retraining six operators and revising the work instruction.

1,002 words, about 5 min 5

"Pin-Compatible" Bluetooth Module: Design Change, Risk File, and Reflow Revalidation

A manufacturer of a blood glucose meter (US Class II, EU Class IIa) with Bluetooth connectivity replaces its BLE module with a pin-compatible module from a new supplier, and changes firmware to support the new stack. The change assessment concluded "no impact on safety or performance - pin compatible." Verification performed: functional testing and EMC testing.

1,086 words, about 5 min