Regulatory and Compliance Consultant
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
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
My passion lies in empowering medical device companies to enhance their performance and reach their goals.
On January 31, 2024, the FDA issued a significant final rule amending the Quality Management System Regulation (QMSR), which aligns closely with ISO 13485:2016. This amendment marks a pivotal step
The shift towards the Medical Device Regulation (MDR) signifies a major transformation within the medical device sector in the European Union and its global partners. This journey through MDR transition
Welcome to our guide on navigating Unique Device Identification (UDI) compliance in the medical device industry. As the healthcare sector continues to evolve, the implementation of UDI systems has become
Welcome to our latest blog post where we will be looking into Own Brand Labelling (OBL) in the medical device sector. This strategy, where companies market and sell medical products
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