As ISO 13485 certification has become virtually a requirement for medical device suppliers, what is/will be the next significant differentiator?


While ISO 13485 is considered the international gold standard of a medical device supplier’s quality management system, the certification, by itself, is not a significant differentiator.

This is due, in part, to the increased pressure on medical device original equipment manufacturers (OEMs) to be fully engaged with what their suppliers are doing. Therefore, a subsequent differentiator is how an OEM’s manufacturing partner mitigates risk along their supply chain.

Just as medical device OEMs must audit their manufacturing partners to ensure their standards for validation and process controls are being met, a manufacturer needs to have controls in place to objectively confirm that their suppliers can capably and consistently deliver high-quality parts.

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