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.
  • With regulatory authorities background, we balance the nation's requirement for patients safety with the need to foster and advance medical options in an environment to limited resources
  • We have experience in the manufacturing environment from start-ups to MNCs, from greenfield sites to mergers and acquisitons. We understand manufacturing targets, needs and limitations
  • We have experience obtaining global registration from CE, US, Asia, ASEAN, and rest of the world (ROW). As a key partner to the sales and marketing function, we can pave the way to generate revenue and meet business targets
  • We together share the same mission, we contribute to healthcare.

Vision To be world-class regulatory service provider and to contribute to healthcare.

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.
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May Ng

BSc (Biochem & Microbio), MSc (BioMedical Eng), Grad Dipl (Medtech manufacturing)



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May Ng I Founder , Regulatory & Quality for Medical Device

Originally from Ipoh, Malaysia, May Ng is currently based in Singapore. She is held in high regard by the regulators in the industry within and beyond the APAC region and is frequently being invited to speak at conferences around the world. May has since set up a regulatory consultancy, ARQon after realising that smaller companies and start-ups need assistance to understand and overcome regulatory guidelines and barriers.

Companies-In the 1990s, May had her start in the In-Vitro Diagnostics (IVDs) industry. Within a decade of work with the Health Sciences Authority (HSA) in Singapore, she played a key role in establishing the medical devices branch and also, the local and ASEAN medical device guidance. Subsequently, she became the Regulatory Director at the headquarters of Biosensors International Group, a manufacturer of interventional cardiology drug-device products for a number of years before setting up ARQon. Currently, May is also the Regulatory and Quality Director in Endofotonics, a start-up manufacturer for In vivo Molecular Diagnostic (IMDx). Additionally, May is in the professional steering committee for the Singapore Manufacturing Federation – Medical Technology Industry Group (SMF-MTIG), Regulatory Affairs Professional Association (RaPro), Standard advisor for Asia Regulatory Professional Association (ARPA), which is part of Asia Harmonization Working Party (AHWP) and the newly formed ASEAN Federation of Medical Device Industry (ASEANMed) which includes Singapore representative from SMF-MTIG and Association of Medical Device Industry (AMDI).

Expertise-Having an in depth knowledge and expertise, May understands the principle of the risk-based control from the regulator's perspective. With her knowledge in biochemistry, microbiology and biomedical engineering, she had reviewed and approved a myriad of medical devices and licences for manufacturers with ISO13485, importers and wholesalers with GDPMD. Moreover, her educational background in Medtech Manufacturing enables her to better understand manufacturing. Her experience in the design and manufacturing sites as well as in the commercial industry enables her to guide all relevant departments during the entire product life cycle on the regulatory strategy and documentation to meet the global registration requirements and compliance:

  • Design & Development: Provided advice and strategy in the design and development phases and technical/quality documentation for the conformity assessment route to achieve CE mark, ISO 13485 certification and other Global approval to meet the local standard, testing, trial and labelling.
  • Product Registration: Prepared and submitted dossier to obtain approval for medical device and drug in EU, US, APAC, ASEAN and Global countries
  • Advisory and Training: Advisory role on regulatory compliance to QA, Clinical, Sales and Supply Chain such as activities on Authority or EU notified body site audit on EU Medical Device Directive (MDD), ISO 13485, Good Manufacturing Practice (GMP), and also other advisory on Site Master File (SMF), Post Market Vigilance and Surveillance (PMV&S), Clinical Trial, Customs clearance and Harmonised Standard (HS) Code.

  • "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 found Singapore to be one of his favourite places to stay. As a senior engineer, he has helped numerous companies in US and in recent years, Asia.

Companies - His experience in Medical Devices encompasses Real-time Blood Gas Analysers, implants (LVAD, Prosthetics), and Laboratory Equipment, and Bio-Pharmaceutical industry.

Expertise - He has in depth knowledge of 21 CFR Part 820 Quality Systems Regulation (Medical Devices), and Part 11 ER/ES, 210, 211 cGMP in Pharmaceuticals plus ICH Q7A GMP and Q9 for API's. Also in ISO 13485 Medical Devices Quality Management Systems Requirements for Regulatory Purposes. His primary work has been in the validating Processes, Utilities, Facilities, Process Control, Sterilization, Computer software, and Equipment, preparation of Site and Project VMP's, and CAPA systems.
In the involvement of QMS and VMP, he helps companies to develop and implement SOP, Document control system, Engineering test runs, Commissioning and Qualifications of IQ, OQ, PQ, FDS's, URS's, FAT, SAT, Quality System review and gap analysis, Quality plan including sampling, traceability, quality control, design review, validation plans, complaint handling, process improvement, yield monitoring, as well as CAPA investigation and resolution.


"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



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Stephen Hsu

PhD molecular biology

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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.
Stephen has a Bachelor's degree in Molecular Cell Biology with minor coursework in Material Science Engineering from U.C. Berkeley and a Ph.D. in Molecular Genetics and Cellular Biology with an emphasis on Cancer Biology from the University of Chicago.

Companies - From a published scientist in advanced cancer research and GCP training, Stephen transitioned to industry by first joining the Singapore's Health Sciences Authority reviewing both clinical and quality dossiers of biologics and chemical NDAs. With advances in new therapeutic products, he led the workgroup to consolidate the legal and regulatory framework for cell- and tissue-based therapies. He was also the editor of the local Drug Registration Guideline. At GSK Vaccines' first greenfield, primary biologics manufacturing site outside of Europe, Stephen headed the quality systems team, helping to deliver the first GMP certification from EMA and HSA 2 years after commissioning. As Quality Assurance Head in Novartis Singapore Pte Ltd, Stephen had comprehensive oversight to streamline, remediate, and improve all GxP-impacted processes. From an organization with critical findings and at-risk result, he was able to turn the situation around and delivers positive audit outcome. Currently in Regional QA Head of a top 10 global pharma MNC, Stephen oversees commercial QA process across the APAC region.

Expertise - Stephen brings with him a wealth of knowledge and experience from regulatory affairs, quality assurance, GCP, GMP and GDP.


“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

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