About Us

About Us
FOREFRONT SYSTEMS provides expertise for all aspects of the medical device, PPE and general products regulatory approval cycle. Our all-inclusive regulatory support includes assistance with EU Technical Files, 510K submission, UK Conformity Assessed and quality management system services, including support for the set-up and organisation of ISO 13485, MDSAP and ISO 9001 quality systems. We also provide consultancy for start-ups importer, or MNC Manufacturer who would like to set up business in Thailand to ensure compliance with all the current and relevant rules and regulations.

Established in July, 2017 and first registered in 2020 as Thailand Business, we provide consulting services to a wide range of businesses in Thailand and the globe.

Meet our team
We have group of experienced independent professionals and specialists in each product category to provide strategic advice.

Over 20 years’ experience working in Quality Management with much of her time spent working in the Medical Device industry, with 15 years of Medical Device Regulatory. Wide-ranging experience in the Medical Device Industry and Medical Device Regulatory Affairs. Involved in numerous successful CE marking projects ranging from class III to self-registration class I devices for European submissions along with US, UK, Canada, Australia, Singapore, Malaysia, China and Thailand registration and submission. Implemented, managed and audited numerous ISO 9001, ISO 13485, US 21 CFR 820, JPAL Quality Management Systems. Qualified Internal and Supplier Auditor.

Educational Background :
Master of Business Administration
B.Sc. of Chemistry
B.Sc. of Engineering /department production of engineer

Global Partners
FOREFRONT SYSTEMS has a range of trusted global partners to support clients who need the regulatory and quality compliance required to bring medical device products to market in the following territories:
Europe – EU Representative
USA - US Agent Service
UK - UK Responsible Person (UK RP)
and other countries
Our partners are carefully selected to ensure they share Forefront Systems’ exceptional standards of professional regulatory and quality expertise at competitive and cost-effective rates. For more information, please contact the Forefront Systems team : contact us