Change – the necessity of time

Changes in today’s world are inevitable, and this is all to keep abreast with the fast technological advancements and to keep the customers happy and content. But when you are in the medical device industry, something you cannot be naive about is that every change comes with a price. 

Changes to devices and their impact

Each time you make a change in your product you must go through a series of questions, such as the following, and corresponding action items to continue providing safe and effective devices to your customers and stay compliant with worldwide regulatory requirements, especially in the countries where you sell. You would want to check: 

  1. Is the change in both hardware and software? Or only software? 
  2. How did the change originate? Was it because of a field event, complaint, performance improvement, bugs, defects, failures? 
  3. What is the impact of the change? Does it affect labels, design, User Interface (UI), bio compatibility? 
  4. What all do I need to update? Do I need to update my Design History File (DHF), technical documentation, etc? 
  5. Whom do I need to notify? Should I be letting the regulatory bodies know, or the customers or the FDA? 
  6. When can I formally implement the change and what are the prerequisites? 


A lot of device companies across the world are struggling with these questions and in identifying the right team and personnel to help close these timely and efficiently with no loose ends. The device and digital healthcare industry shall see most changes in the coming years and it’s time we think of these and help ourselves by preparing preemptively.

#elexes #healthcare #medicaldevices #change #dhf #fda #digital #quality #software

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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