Company |
ARQon was formed as we recognized the needs of manufacturer start-ups for regulatory guidance on the product development phases to commercialization to obtain CE, and access to markets in US, Asia and the rest of the world. The team was formed from individuals with vast experiences in medical device and drug manufacturing sites, trading industry and in regulatory authority.
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Vision |
To be world-class regulatory service provider and to contribute to healthcare.
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Mission | To utilize our regulatory skills, expertise and connections to help our clients to resolve and comply with the regulatory requirements to meet the quality, safety and effectiveness for medical device and drugs and obtain approval for healthcare use. |
May Ng BSc (Biochem & Microbio), MSc (BioMedical Eng), Grad Dipl (Medtech manufacturing) |
May Ng I Founder , Regulatory & Quality for Medical Device
May Ng is originally from Ipoh, Malaysia and is currently based in Singapore. May is held in high regards by the industry and regulators alike both in the APAC region and outside and continues to be invited to speak at conferences across the world. Following the family philosophy and seeing an unmet need for smaller companies and start-ups to understand and overcome regulatory guidelines and barriers, she set up ARQon to make a positive contribution to healthcare.
"Regulatory requirements allows the manufacturer to demonstrate that their product is safe, effective and with good quality. With the correct regulatory strategy and early planning, unnecessary delays can be avoided due to subsequent queries or even missing critical documents. With ARQon's support in regulatory planning, we add value to the top line and bottom line by getting product approval months or even years earlier." |
Mike Bjordstads I Quality and Process Validation
Mike Bjordstads has been based in US for past 20 years before he finds Singapore as one of his favourite place to stay. As the senior engineer, he has helped companies in mostly US and in Asia in recent years. "Risk Based Quality Management System, Process and Product Validation can be timely and expensive for MedTech companies. ARQon provides value added strategies to Qualify Facilities, Equipment and Processes." |
Mike Bjordstads Engineer |
Stephen Hsu PhD molecular biology |
Stephen Hsu I Biologics & Drugs
Stephen Hsu spent his formative years in San Diego. As a Taiwanese-American, he relocated to Singapore to contribute to the amazing growth in Asia as well as to leverage his cross-cultural understanding and multiple language-skills.
“Quality is a journey. While nearly everyone realizes that there's costs associated with a low-levels of quality, i.e. risks to patient safety, non-compliance, rejection, rework, recall, etc., however, there's also costs associated with too-high a level of quality, i.e. unnecessary redundancy, complex and overly bureaucratic processes, delays to release and market. The key is to balance the quality requirements in the specific environment to maximize effectiveness of available resources, leveraging on all available scientific data, without undue high-risk compromises.” |
We have the team members in our organization, with experience from local manufacturing site and MNC, and handled commercial product registration experience worldwide. Our subject matter technical team handles testing and questions from authority on biocompatibility, sterilization, stability, electrical and mechanical. |
Expertise categories |
STED I CSDT I QMS I ISO 13485 I GMP I Biologics I Drugs I Food I Validation I Process I Design Histrory File I Technical File I |