Author name: Abul Ehsan

This is Abul Ehsan, I bring over ten (10+) years plus of extensive experience in quality and regulatory compliance consultancy for medical devices. Throughout my career, I have helped numerous clients navigate the complex Regulatory landscape, Achieve global market access, and Optimize their quality management systems. My expertise includes holding certifications such as QMS Lead Auditor (ISO 13485:2016) and ISO 9001:2015 Internal QMS Auditor. I have developed proficiency in various areas, including SOP authoring, Risk management, and New business development. My passion lies in empowering medical device companies to enhance their performance and reach their goals.

Blogs

CE Marking Process: Ensuring Medical Device

Abul Ehsan / March 7, 2024

The CE marking process is a pivotal step for manufacturers looking to distribute their: This mark signifies compliance with the […]

Own Brand Labelling- The Ins and Outs

Abul Ehsan / January 24, 2024

Own Brand Labelling (OBL) in the medical device industry was a term used to define companies that market and sell