ISO/IEC 17025:2017 - Testing and Calibration Laboratories Lead Auditor Quiz 07 24Mar25 - Practice Quiz

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Question 1 of 30

\"MediTech Solutions,\" a burgeoning medical device manufacturer specializing in innovative glucose monitoring systems, is diligently working towards ISO 13485:2016 certification. As part of their preparation, they\'ve established a comprehensive risk management process. During the design and development phase of their latest continuous glucose monitor (CGM), the risk analysis identified a potential hazard: inaccurate readings due to electromagnetic interference (EMI) from common household appliances. The initial risk assessment, based on the likelihood of EMI exposure and the potential severity of incorrect insulin dosage decisions, placed this risk above their pre-defined acceptance criteria. Considering the requirements of ISO 13485:2016, what is the MOST appropriate next step for MediTech Solutions to undertake regarding this identified and evaluated risk?

Implement risk control measures to reduce the risk of inaccurate readings due to EMI, followed by verification of the effectiveness of these measures, and maintain documented evidence of the entire process.

Accept the risk, document the rationale for acceptance in the risk management file, and proceed with the design transfer to production, focusing on cost-effectiveness.

Re-evaluate the risk acceptance criteria to align with the identified risk level, thereby avoiding the need for costly risk control measures and maintaining project timelines.

Defer the implementation of risk control measures until the post-market surveillance phase, relying on user feedback to identify and address any instances of inaccurate readings due to EMI.

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