11 Reasons Why Medical Device Remediation Goes Wrong

In most regulated industries remediation is a cost of doing business.?Unfortunately, the medical device industry is no different.?While remediation won’t hit every business, the fact of the matter is as regulations continue to change and or grow more companies will find themselves in a spot where they are having to change their processes and procedures in order to remain in compliance.

In 2021 we wrote about the keys to success,?identifying six (6) key areas of focus to help one get through remediation?and come out on the other end still in tact and moving forward.

As the medical device industry continues to evolve, so must our approach to solving problems we face.?As such, understanding the reasons why a device company may experience failure as they go through remediation is key to learning from others mistakes so we don’t repeat them when it comes our turn.

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WHY THINGS GO SIDEWAYS

the top 11 reasons why remediation goes wrong for medical device OEMs:

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1. ROOT CAUSE: failing to fully understand the root cause of the issue and or not adequately addressing all aspects of the problem
2. PREVENTION: neglecting to update or improve processes to prevent future issues
3. REGULATORY COLLABORATION: insufficient communication and partnering with regulatory agencies

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