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Abul Ehsan

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

  • 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.

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My Key Areas of Expertise in Medical Device Consultancy

  • Expertise in regulatory compliance for medical devices, ensuring adherence to industry standards and regulations.
  • Proficient in quality assurance methodologies to maintain product quality and safety throughout the manufacturing process.
  • Skilled in design control processes, overseeing the development and implementation of product design strategies.
  • Experienced in validation planning, establishing protocols and procedures to validate product performance and efficacy.
  • Specialized in contract recruitment consultancy for the medical device industry, providing tailored staffing solutions to meet client needs.

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