Certbie
Question 1 of 30
BioTech Solutions, a manufacturer of implantable cardiac pacemakers, is revising its supplier selection process to align with ISO 13485:2016 requirements. Dr. Anya Sharma, the Quality Manager, has identified three potential suppliers for a critical component: the battery that powers the pacemaker. Supplier Alpha has a well-established QMS certified to ISO 9001 but lacks specific experience in medical device components. Supplier Beta has extensive experience supplying similar components to other medical device manufacturers but has a history of occasional late deliveries. Supplier Gamma is a new entrant to the market, possessing innovative technology and competitive pricing but lacks a mature QMS and a limited track record. According to ISO 13485:2016, what is the MOST important factor Dr. Sharma should prioritize when evaluating these suppliers to ensure compliance and minimize risk to patient safety?
Conducting a comprehensive risk assessment that considers the potential impact of each supplier's products or services on the safety and performance of the pacemaker, and implementing controls proportionate to the identified risk level.
Prioritizing Supplier Beta due to their extensive experience in supplying similar components to other medical device manufacturers, as this demonstrates a proven track record and reduces the likelihood of quality issues.
Selecting Supplier Gamma based on their innovative technology and competitive pricing, as this will provide a competitive advantage and potentially improve the pacemaker's performance.
Choosing Supplier Alpha because they have a well-established QMS certified to ISO 9001, which ensures a baseline level of quality and reduces the need for extensive audits and inspections.

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