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Author: Anne Holland, CEO and Founder

A medical device gap analysis evaluates your current Quality Management System (QMS) compared to industry standards and regulations to determine if any gaps exist between them.

An effective gap assessment will help you understand the following about your QMS:

  • Where you are in compliance
  • What aspects are not in full conformance
  • How to become compliant with existing and upcoming regulations
  • If your system is “state of the art”

The gap analysis should also help you identify potential risk areas so that you can prioritize and plan ahead.

Read on to determine if it is time for your organization to conduct a medical device gap analysis. 

Three Times a Gap Analysis is Critical

While there is no regulation or requirement to conduct a gap analysis, our recommended best practice is to perform one every year prior to Management Review.

A regular cadence will help your organization avoid potential regulatory and compliance roadblocks before they become an issue.

However, if a regularly scheduled gap analysis is not on your radar, our team has identified three key situations when it is critical to conduct one:

  1. Impending regulatory changes and updates.
  2. Upgrading or changing your existing QMS.
  3. Preparing for an ISO 13485 audit.

A gap analysis at these critical junctures provides your company with essential benchmarking data to help you mitigate risk and avoid potential regulatory and compliance roadblocks.

Lean Into Our Medical Device
Gap Analysis Expertise

Without a regular assessment of how your QMS implementation measures up, your company risks non-compliance, delaying the timeline to get your product to market, and potentially serious financial consequences down the road.

Schedule a free discovery call to determine if a gap assessment is appropriate for your company.

A gap analysis conducted by a knowledgeable team of medical device consulting experts can quickly identify areas of risk and non-compliance before they become a problem.

Mind the gap so you don’t have to spend time, money, and resources on preventable compliance issues.

We’ve been providing medical device quality consulting services for more than 20 years. Let’s get the quality conversation started!