active medical devices

Validation of a quality management system

Certification plays a major role in building trust. Especially when we consider items like medical devices, certification is the crucial factor.  The iso 13485 certification Malaysia is the most important international standard here for quality management systems related to medical devices. Before certifying there will be quality management practices which the medical devices should undergo and these practices mainly focus on development and design of the device. Along with that when certifying they will also consider assembly, customer service, and event production. To get certified, one must consult a quality management system in Malaysia. There are a lot of benefits to this validation through quality management system.

active medical devices

The certification which is received from the experts allows following things.

  • You can communicate through the high standards of quality
  • Through the independent certification, it i8s possible for you to gain a competitive edge
  • With the help of accreditation received, portray as a notified body for all the medical devices you produce

To receive the ISO certification there will be a preliminary assessment. At this stage, the quality management system will come and inspect the site and they will review the quality management documentation. After that there will be initial stage of certification audit. This is considered as phase 1. In this, they will determine whether site is actually eligible for certification. In phase 2, they will examine the quality management system in practice and they will also evaluate the effectiveness. Finally if the system meets all the required criteria, then they will issue the certificate. This tells that the system is in compliance with the standards.

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