A blue-chip consumer healthcare products company asked Alacrita to provide a medical device consultant to audit the mainland Europe manufacturing site of a potential supplier against ISO 13485. ISO 13485 is the International Organization for Standardization (ISO) standard that sets out the requirements for a comprehensive quality management system for the design and manufacture of medical devices. The current edition was published in 2016, and certification to it is widely expected by regulators and brand owners as evidence that a manufacturer can produce devices consistently and safely.
The client wished to assess whether the supplier could manufacture a novel medical device that was to be marketed under the umbrella of one of its major household brands. Because of the importance of that brand, the client needed a high level of confidence in its medical device supply chain before committing to the supplier. A shortfall in the supplier's quality system or manufacturing capability could have affected product quality, regulatory standing, and the reputation of the brand.
The Alacrita medical device consultant carried out an in-depth review of the supplier's capabilities. This included an audit of its ISO 13485 quality management system, a review of its existing medical device technical files, and an expert assessment of its technical capability to manufacture the product. Together, these showed the client how well the supplier's quality system and documentation met the standard, and whether the site was equipped to make the device to the required specification.
The client needed a decision on the supplier's suitability urgently. Alacrita's ISO 13485 auditor completed the audit and reported the findings within three days, giving the client the information it needed to proceed with its supplier decision.
Alacrita draws on medical device consultants with niche quality, regulatory, and manufacturing expertise, which allows it to deliver this kind of assessment on tight timelines when a commercial decision depends on it.