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A medical device inspection. Ah! Is there a more dreaded exercise for a medical device manufacturer? If I were given a choice between taking up the world’s toughest rated examination and facing a medical device inspection, I would gladly opt for the former. A medical device inspection should rank right there ahead of the most difficult examination or task.
Alright. We knew this fact all along. So, why should I intimidate you by casting such aspersions on a medical device inspection? Fact is, a medical device inspection’s stringency is a little overrated. Am I not contradicting myself? On the surface, yes, but scratch a bit, and you will realize the truth of what I am saying.
Yes, medical device inspections are extremely difficult to the point of being scary. But the fundamental question is, for whom? A medical device inspection is a difficult one for only those who are unprepared for it. In other words, a medical device inspection is just like a highly rated competitive exam: it is tough if you are unprepared and manageable if you are prepared.
So, in what way can a medical device manufacturer prepare for a medical device examination? I want to present the ultimate guide to medical device inspection, which I believe is going to live up to just what I am calling it: the ultimate guide to medical device inspection.
The basis to a medical device inspection is just one mantra: prepare, prepare and prepare. I already know it and I don’t need you to tell me this, you may say. But how to prepare and what to prepare for is the question. I will try to make my ultimate guide to medical device inspection as comprehensive as I can and will try to shed as much light on as many areas of it as I can, while trying to keep it simple.
Let us begin at the beginning. Some medical devices are designed newly. Many build on what is already there in the market and some are completely off the block. The first step to my ultimate guide to medical device inspection is to understand this aspect of a medical device. Is your device a new one or is it being developed based on an existing device’s core? Many devices alter or extend an existing one to stretch its uses to a new or untapped market. The entire nature of the medical device inspection can depend on this nature of the medical device. So, classifying your medical device into its right slot is the first step in this ultimate guide to medical device inspection. Conceptualizing what your medical device is like is half the work done.
Regulations are at the heart of medical device inspections. All inspections look primarily for the extent of compliance to regulations. In perhaps no other industry is regulation of such vital importance than in the field of medical devices. Getting the regulations right is the foundation of a successful medical device inspection and quite easily qualifies in the ultimate guide to medical device inspection. Companies have enormous resources in the form of FDA literature (or that of other regulatory bodies if the product is marketed in those jurisdictions) and expert guidance.
My sincere exhortation: please do not hold back your purse strings in this most important of areas. If you try to economize and satisfy yourself that you have saved a few dollars here, think of what you will be required to cough up if your device fails to meet regulatory standards. The penalties are of such order that you may even have to shut shop like so many others that have met the same fate. Make sure the regulations are adhered to each and every stage. The consequences of staying compliant are simply too many and all of them are of a positive nature.
Keep a very sharp eye on Design Controls
Design Controls constitute the next point in the ultimate guide to medical device inspection. This is another of the areas in which the FDA is unsparing when it comes to penalizing medical devices companies that don’t meet the requirements. Learn all the intricacies of Design Controls and understand the criticality of documentation in Design Controls. In addition to helping you to meet regulatory standards, it also makes your own life easier. Documentation enables you to quickly track any activity that the inspector may want to examine. It helps you guarantee and assure your activity at every stage. This diagram is neatly indicative of what the FDA expects the Design Control flow to be like: