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February 1, 2023

BS EN ISO 13485:2016/A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes

The release of the 2021 Amendment of ISO 13485:2016 has created a lot of curiosity amongst medical device organizations and quality professionals. 

The question which most of us have...

September 30, 2022

ISO 15223-1:2021 Medical Device Symbols – An indispensable part of labeling

As we all know that symbols play a very important part in medical device labeling, hence it is critical to know when the relevant standard undergoes changes. If you are a medical device manufact...

September 30, 2022

BS EN ISO 13485:2016/A11:2021

Medical devices – Quality management systems – Requirements for regulatory purposes

The release of the 2021 Amendment of ISO 13485:2016 has created a lot of curiosity amongst ...

September 30, 2022

ISO 20417:2021

Medical devices – What information is to be supplied by the manufacturer?

As we are very much aware that the ISO 20417:2021 standard is already in town, Elexes Team has de...

September 22, 2022

Looking for an ISO 13485 Certification?

Introduction to Quality Management System

Quality is the most important criterion to be fulfilled by medical device manufacturers to satisfy customers. Medical devices have an impact on t...

September 21, 2022

Why and how do Medical Device Manufacturers conduct an Internal Audit?

The purpose of conducting an Internal Audit is to evaluate the efficiency of an organization in terms of quality processes, risk management, and overall business practices with respect to applic...

January 12, 2022

ISO 10993-12:2021

Biological evaluation of medical devices – Part 12: Sample preparation and reference materials

We all are aware that the 2021 version of the ISO 10993-12 has been released and there...

June 3, 2021

The Harmonized ISO 13485 – A Brief Insight!

Can you imagine using life-saving medical devices that have not been certified for quality, safety and efficacy?

These aspects if compromised, can result in enormous adverse effects and a...

June 3, 2021

Quality Sytems: Facilitating continuous improvement!

What is continuous improvement and how can we achieve it? An answer to this is a premeditated and well-implemented quality management system (QMS).

A QMS, in simple words, is a system in ...

June 3, 2021

Document Control System: The Core of Quality Management System

Has managing documents always been a tedious and time consuming task for you? Have you faced issues of cost drain and compliance while maintaining the documents for medical devices?  We und...