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  • Writer's pictureLungtreater

Regulatory requirements are increasing for medical devices!

Updated: Aug 1, 2018

Many company find themselves in a catch up mode when it comes to their quality system. However a well organized, product specific system that employs strong risk management techniques and embraces pre and post market surveillance should keep your organization on track.



Whether you’re running a small business or a large organization a simple and well thought out quality system is the key. Focussing on Quality rather than compliance is a key to creating a culture of quality that will satisfy your regulatory requirements.


With cybersecurity concerns and growing regulatory requirements, experts scramble to bring products to market.

Bringing products to market is getting tougher and more expensive. Keeping them on the market now has additional requirements that an organization must embrace.


Here’s whats happening:

  1. It's time to be sure you are 2016 13485 certified.

  2. Notified bodies are under scrutiny from their competent authorities.

  3. ISO 14971 Risk Management is due for an update.

  4. The FDA is now focussing on pre and post market surveillance throughout your products life cycle.

  5. Cybersecurity concerns are real.

The regulatory environment is ever changing. Make sure you avail yourself of our knowledge.

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