ISO 13485:2016 Transition Challenges: A Small Manufacturer Perspective

​A straightforward Google search of "ISO 13485 Certification transition" will lead you to plenty of information, tool compartments, experts, and agendas. These are extraordinary resources accessible to assist organizations with finding out about the significant corrections, and they can fill in as an incredible beginning stage, yet the data isn't generally a "one size fits … Continue reading ISO 13485:2016 Transition Challenges: A Small Manufacturer Perspective

Things You Should Know About ISO 13485 Certification

1. What is ISO 13485? ISO 13485 is the worldwide global standard for the foundation and upkeep of a reported quality management system in the medical industry. If a producer has carried out ISO 13485 Certification, it's anything but an establishment whereupon to ensure medical device regulations. 2. Coronavirus features sanitation requirements. Makers of medical … Continue reading Things You Should Know About ISO 13485 Certification

Difference between ISO 9001 Certification and ISO 13485 Certification

What is ISO 9001 Certification? ISO 9001 Certification is the Quality Management System for the organization to develop and enhance the quality in the process and procedure continually. It demonstrates the ability to meet customer requirements and needs by providing them high-quality products and services. ISO 9001 Certification is the only standard with a powerful … Continue reading Difference between ISO 9001 Certification and ISO 13485 Certification

How to implement ISO 13485 Certification

​To get Implementation of ISO 13485 Certification to your organization follow the steps listed below:Product conformity is important across all industries but it's especially crucial for medical devices. To maintain consistency in the quality of medical devices from batch to batch, ISO 13485 a quality management system (QMS) standard designed specifically for medical devices. To … Continue reading How to implement ISO 13485 Certification

Difference between ISO 13485 and ISO 9001 Certification

ISO 13485 Certification is quality management for medical devices shares many similarities and differences with ISO 9001 Certification, the leading quality management standards developed by the International Organization for standardization. While most revised standard follows ISO 9001’s new high-level structure Annex SL Structure, but ISO 13485 does not follow HLS, even though it was released … Continue reading Difference between ISO 13485 and ISO 9001 Certification

ISO 13485: Medical Devices QMS

ISO 13485 is an international standard for a medical device system for an organization to develop and demonstrate a quality management system that consistently meets customer and applicable for regulatory requirements. The safety and quality of the public cannot be kept at risk. In order to demonstrate continual improvement and maintain the new adoption of … Continue reading ISO 13485: Medical Devices QMS