Weekly columnLeda Longhi
Consultant specialising in regulatory affairs and quality management for medical devices. Exemplar Global-certified Lead Auditor for ISO 13485:2016 QMS and MDSAP, with experience in registration with ANVISA and Latin American regulatory authorities.
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QualityA special process is not audit jargon - it is the factory's most misunderstood risk category
If your process output cannot be verified by inspecting the finished product, you are dealing with a special process - where failure does not show up in the component, but in the patient.
QualityYour sterilisation cycle is validated. But did you validate the right product under the right worst-case conditions?
An approved cycle shows that the equipment delivers the process - not that the most challenging device, in the most demanding load, achieves the required SAL. This confusion is one of the sector's costliest gaps.
QualityPackaging does more than protect the product. It maintains sterility - and that takes different engineering
Physically protecting a product and maintaining a sterile barrier throughout its shelf life are distinct objectives requiring distinct validations. Sterility only reaches the patient if the packaging preserves it.
QualityFour Regulatory Requirements, One Validation System (QMSR, MDR and RDC 751)
ISO 13485, FDA QMSR, MDR 745/2017 and RDC 751/2022: treating each framework as a separate project multiplies costs and weakens your case. The solution is one system interpreted through several regulatory frameworks.