Online Safety Community

The [Ultimate Guide] To Medical Device Inspection

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.

Conceptualization

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!

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:

This link https://goo.gl/5Yn6MF has more on this topic for your reference

Views: 40

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Nakul Pratap posted a photo
7 hours ago
PosheSolutions posted a photo

Nebosh Health and Safety at Work

Get Nebosh leadership excellence with excellent Trainers @poshesolutions. Introductory Offers Goin On. Grab this Excellent Offer for fundamental health and safety qualification. #nebosh-qualification
7 hours ago
Profile IconAndrew Wilbourn, Simon Foley and Norm Grimberg joined Online Safety Community
7 hours ago
Mark Nilson posted events
16 hours ago

Forum

Workplace safety for workers other than your own 3 Replies

Do your workplace/traffic safety plans include safety measures for workers who are not your own employees? Do they take into account the safety of those who will be - or could be - at your workplace,…Continue

Tags: emt, paramedics, emergency, occupational, health

Started by John Petropoulos Memorial Fund. Last reply by Paul Lancaster May 28.

Imagine a technology which is an artificial muscle and is integrated into textiles...

Such a smart textile has huge application potential and can support people in many different ways. The garment would use haptic feedback (i.e. the use of touch to guide the user) or could serve as a…Continue

Started by Ulla Siegel May 28.

Green Smart Technical 800+ Turnkey Projects in UAE – Rope Access Company in Dubai

Green smart is an ISO 9001: 2015 QMS, OHSAS 18001: 2017 OHSMS, ISO 14001: …Continue

Tags: window, cleaning, services, facade, companies

Started by Manikandan Apr 23.

What % of Dollars should be bugeted for All Safety Training for a "Heavy Equipment Road Construction" company with 100 employees? 1 Reply

I have been at a Highway and Road Construction company for six months. I am developing a (first) complete training program. I am the 1st full time safety hire for this company. I need to develop a…Continue

Started by JTurpening. Last reply by Jen McDade Feb 19.

Technology and Safety 1 Reply

What are the most useful tools to have at your fingertips? -Toolbox Talks-JSA-JHA-Daily Reports, etc. What is falling through the cracks that could be an easy fix? Safety Managers, Coordinators and…Continue

Tags: safety

Started by Drew stone. Last reply by Jen McDade Feb 15.

Badge

Loading…

© 2019   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service