Understanding Medical Device inspection

The medical device inspection process is built on the logic that methods are not to be considered the criterion for evaluating and inspecting a medical device.

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A medical device inspection is one of the most important activities the FDA carries out to determine that a device meets the requisite regulatory standards for ensuring safety and effectiveness. It is a core GMP activity and hence covers all medical devices ranging from the smallest to complex ones such as MRI’s.

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Rationale for the medical device inspection regime

The medical device inspection process is built on the logic that methods are not to be considered the criterion for evaluating and inspecting a medical device. This is because many methods can be used to arrive at the same product, due to which the choice of the best option is left to the manufacturer. Given this fact, the FDA medical device inspection concept is aimed at inspecting the device’s Quality System Regulations (QSR)-mandated objectives, which are a more precise parameter for medical device inspection.

What are manufacturers expected to demonstrate to a medical device inspection?A medical device inspection is done to ensure that the device meets set safety, efficiency and intended use standards, while being compliant with regulatory requirements. During the medical device inspection, manufacturers have to demonstrate that the method they have chosen to use -since there can be varied methods for arriving at a medical device specification -is helpful in arriving at the product while meeting the prescribed regulatory compliance requirements. They should defend the methods they have used in ensuring regulatory compliance requirements.

Need not meet all GMP requirementsOne major factor that the FDA keeps in mind for a medical device inspection is that manufacturers are not required to show compliance with each and every Quality System (QS) or GMP section. Only those that are relevant to that device can be shown, but they should be able show which sections of the GMP or QS are relevant to the said device, and should also show how these have been used to arrive at the product that is compliant in terms of regulatory requirements.

Factors a medical device inspection takes into considerationDuring a medical device inspection, the FDA inspectors keep in mind a few factors that help them determine the efficiency and effectiveness of a medical device. Some of the important ones among these include:

  • Has the manufacturer documented the processes in the right format? Has everything related to it been written down?
  • Is the manufacturer complying with those processes?
  • Is there sufficient evidence that these are adequate?

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Other issues for a medical device inspectionThe FDA does a medical device inspection keeping these factors in mind while also weighing other issues such as the size of the medical device manufacturing firm, the complexity of the device under inspection, and the nature and gravity of risk a device that does not meet its intended specifications poses.

Author: compliance4all

Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits. Industries We Focus On: • Trade & Logistics • Aerospace Defense • Banking & Insurance • Food & Beverages • Auditing/Accounting & Tax • Energy • Environment • Education • Automotive Transport • Science and Technology • Government • Construction • Electronics & Semiconductor • Operation • Engineering/Science • Purchasing & Vendor Relation • General counsel/Accountant • Geology & Mining • Documentation/Records

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