ISO 13485 Certification Requirements- Medical Devices QMS

  • October 03, 2018
  • Dushyant Sharma
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Quality management associated with Medical devices can get a form of certification that show off that the quality of the maintenance, the structure, the integrity and the usage of the medical devices are up to the international standard. This international standard is defined by ISO 13485.The process associated with the certification is quite conventional. The same goes for the ISO 13485 certification requirements

ISO 13485 Certification Documents Required

With ISO 13485 certification, you can ensure that your company is the one that can be trusted in matters associated with the QMS of medical devices. That being said, the process of getting this certification needs an expert assistance. This assistance is further accentuated upon when you consider that the documents associated with the ISO 13485 certification process are quite intricate as well:

1. Quality Manual: in order to get your company up to the international standards, you need the ISO 13485 standard at your side. This particular standard is the culmination of all the dos and don’ts associated with the Quality management system of medical devices.
2. Quality policy associated with the medical devices of the company
3. The records associated with the quality of the medical devices
4. The procedures associated with the quality management system. These procedures entail the following: 

  • Document control
  • Record Control
  • Internal Audit
  • Control associated with the product that not conforms to the standards
  • Corrective action taken to rectify the above product
  • Preventive action to be taken in the event product failure.

These are the documents that you need in order to apply for the certification and get yourself, certified.

As you might have observed, some of the documentation given here can be pretty hard to comprehend. There is no point in worrying about it, for our team of Registrationwala is here to assist you through the entire procedure and that includes document accumulation. 

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Dushyant Sharma
Author: Dushyant Sharma

Hey there, I'm Dushyant Sharma. With the extensive knowledge I've gained in past 8 years, I have been creating content on various subjects such as banking, insurance, telecom, and all the important registration and licensing processes for various companies. I'm here to help everyone with my expertise in these areas through my articles.

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