About Us
About Us
Regulatory & quality consultants for the medical device, PPE and general products approval cycle — in Thailand and across the globe.
Expertise across the full approval cycle
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, 510(k) submission, UK Conformity Assessed and quality management system services — including set-up and organisation of ISO 13485, MDSAP and ISO 9001 quality systems. We also provide consultancy for start-up importers and MNC manufacturers who would like to set up business in Thailand and ensure compliance with all current and relevant regulations.
Established in July 2017 and first registered in 2020 as a Thailand business, we provide consulting services to a wide range of businesses in Thailand and globally.
Specialists in every product category
We have a group of experienced independent professionals and specialists in each product category to provide strategic advice.
Over 20 years' experience in Quality Management, much of it in the Medical Device industry, with 15 years of Medical Device Regulatory. Involved in numerous successful CE marking projects — from class III to self-registration class I devices — for European submissions, along with US, UK, Canada, Australia, Singapore, Malaysia, China and Thailand registration. Implemented, managed and audited numerous ISO 9001, ISO 13485, US 21 CFR 820 and JPAL Quality Management Systems. Qualified Internal and Supplier Auditor.
Educational Background- Master of Business Administration
- B.Sc. of Chemistry
- B.Sc. of Engineering — Production Engineering
A trusted network worldwide
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.
Let's bring your product to market
Our partners share Forefront Systems' exceptional standards of regulatory and quality expertise at competitive, cost-effective rates.