Certbie
Question 1 of 30
A small medical device company, \"MediTech Innovations,\" has recently launched a new Class II medical device in the European market. As the lead auditor for their upcoming ISO 13485:2016 surveillance audit, you are reviewing their post-market surveillance (PMS) system. MediTech has established a system for collecting customer complaints and adverse event reports, but they primarily rely on passive data collection and have not implemented any proactive methods for gathering post-market data. During the audit, you discover that MediTech\'s PMS procedures do not include a mechanism for systematically analyzing data from competitor devices or relevant scientific literature to identify potential safety signals. Considering the requirements of ISO 13485:2016 and the importance of a comprehensive risk management approach, what is the MOST significant concern regarding MediTech\'s current post-market surveillance system?
The lack of proactive data collection methods and the absence of a systematic analysis of external data sources (e.g., competitor devices, scientific literature) to identify potential safety signals, which limits the effectiveness of risk management and continuous improvement efforts.
The absence of a formal procedure for documenting the training records of personnel involved in post-market surveillance activities, potentially leading to inconsistencies in data collection and analysis.
The failure to conduct regular management reviews of the post-market surveillance system, hindering the ability to identify areas for improvement and ensure the system's ongoing suitability and effectiveness.
The lack of a defined process for verifying the accuracy and completeness of customer complaints and adverse event reports before they are entered into the post-market surveillance database.

Preparing for ISO/IEC 17025:2017 - Testing and Calibration Laboratories Lead Auditor? Now land the interview.

73% of qualified candidates get rejected because of weak resumes. Build an ATS-optimized, recruiter-ready resume in under 5 minutes - free to start.

Build My Resume Free