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...

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...

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 ...

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...

Software as Medical Device (SaMD)

The software has become an integral part of almost all facets of life. It has pronounced usage in the healthcare and medical field. There are three types of software related to medical devices.<...

Quality Objectives – Driving Improvements

Learn about the importance of Quality Objectives (QO), how are they important for a medical device company’s Quality Systems, and how to draft accurate Quality Objectives intended to drive impro...