DH RegSys
What We Do
Trusted Regulatory and QMS Consultants
for the Medical Device Industry
DH RegSys provides consultancy services to the medical device industry, specialising in Quality Management Systems (QMS) and Regulatory Affairs. Led by our Principal Consultant, Hwee Ee, who brings close to 40 years of industry experience, we support clients in navigating complex regulatory pathways with confidence.
To complement our consulting services, we also offer training services in QMS and Regulatory Affairs. Our training equips clients with practical, actionable knowledge and can also serve as a refresher. They include insights and tips drawn from our consultants’ hands-on industry experience and best practices.
Our Guiding Principle
DH RegSys believes in seamless working relationships within the organisation, with associates and clients. Such relationships have to be built on the foundation of mutual respect and trust with continuous nurturing.
“合作无间尚崇礼“
(hé zuò wú jiān shàng chóng lǐ)
Meet Our Team
Tan Hwee Ee
Our Founder & Principal Consultant
Hwee Ee has close to 40 years of experience in the medical device industry in Quality Assurance and Regulatory Affair roles as a consultant, engineer and senior manager. She is a member of the Global Harmonization Working Party Towards Medical Device Harmonization (GHWP) WG7.
Her areas of expertise include Quality Management Systems (ISO13485-2016 and 21CFR Part 820), product quality assurance (QA), and regulatory requirements of countries for product registration such as: Singapore (HSA), Malaysia (MDA), Australia (TGA), the USA (FDA), and Europe (EU MDR & IVDR).
Besides these advisory services, Hwee Ee has been actively involved in conducting public and in-house training.
Andrew Ho
Co-Founder & Business Development Director
Andrew is the co-founder of DH RegSys. He started his journey in the medical device industry with primary responsibility on the development of business for DH RegSys’ QARA consulting services.
He is the key liaison to the company’s regional partners, providing regulatory services across the region (e.g. Malaysia, Thailand, Philippines, Indonesia and Vietnam).
Besides consulting services; Andrew also focuses on delivering training to the industry via seminars (e.g. Medical device regulatory workshop for China, Japan, and ASEAN countries) and workshops (e.g. SaMD/IEC62304; Risk management).
DH RegSys 