Helping medical device organisations evaluate, qualify and monitor suppliers through risk-based audits, CAPA follow-up and stronger controls across the supply chain.
A supplier issue can quickly become a quality or compliance issue for the manufacturer. DnA helps organisations look beyond basic vendor approval by assessing supplier criticality, reviewing actual performance and establishing controls based on the risk each supplier brings to the product.
Qualifying new or critical suppliers before approval
Conducting independent supplier and vendor audits
Investigating repeated supplier findings or performance concerns
Reviewing corrective actions and CAPA effectiveness
Assess supplier capability, criticality and quality requirements before approval, with controls proportionate to the supplied product or service.
Conduct focused audits using document reviews, process interviews and evidence sampling to identify gaps against defined quality requirements.
Review supplier responses, root causes and corrective actions to determine whether findings have been properly addressed and recurrence risks reduced.
Supplier control should continue long after the initial approval. DnA Regulatory Solutions helps organisations establish a more disciplined approach to supplier monitoring, audits, changes and re-evaluation so emerging quality issues can be identified and addressed before they create wider compliance concerns.
Classify suppliers according to product, service and quality risk
Monitor performance, changes, findings and corrective actions
Re-evaluate supplier suitability using documented evidence
Control That Follows the Risk:
Not every supplier requires the same level of oversight. DnA helps organisations focus stronger controls on suppliers whose products, processes or services can have a greater impact on medical device safety, performance and compliance.
Qualification helps determine whether a supplier can consistently meet defined quality and regulatory expectations, particularly when supplied products or services can affect device safety or performance.
The audit can involve document review, process discussions, evidence sampling and assessment of controls against defined quality requirements.
Yes. DnA can review root causes, proposed corrective actions and supporting evidence to assess whether identified issues have been appropriately addressed.
Move beyond basic vendor approval with qualification, audit and follow-up activities shaped around the actual risk each supplier introduces.