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Company
ARQon 是一家面向医疗器械和药品公司的法规咨询公司。我们协助客户在从产品开发到产品注册的各个环节的法规和质量方面，以获得在亚洲、东盟、欧盟、美国及世界其他地区的市场准入。我们的客户范围包括来自初创企业和跨国公司的研究人员、制造商和贸易商。此外，ARQon 还为研究人员、制造商和监管机构提供培训课程。
Vision
To be world-class regulatory service provider and to contribute to healthcare.
Mission
我们致力于利用团队在监管、商业和人脉方面的专业知识，协助客户制定全球市场战略、解决问题、遵守监管要求并获得批准，从而确保医疗器械、治疗药物和药品的质量、安全性和有效性。我们旨在为全球医疗保健行业和医疗技术社区提供全方位的服务。
Team
We are formed from individuals with vast experiences in medical device and drug manufacturing sites, trading industry and in regulatory authority.
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凭借监管机构的背景，我们在有限资源的环境中平衡国家对患者安全的要求与促进和推进医疗选择的需求。
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我们在从初创公司到跨国公司，从绿地项目到并购的制造环境中都有经验。我们了解制造目标、需求和限制。
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我们有从CE、美国、亚洲、东盟及世界其他地区（ROW）获取全球注册的经验。作为销售和市场职能的重要合作伙伴，我们能够开辟道路以创造收入并实现业务目标。
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我们共同分享相同的使命，我们为医疗保健做出贡献。
Global Regulatory & Quality Director, ARQon group CEO
Bsc (Biochem & Microbio)
MSc (BioMedical Eng)
Grad Dipl (Medtech Manufacturing)
May
Medical Device: Combination, Implants, IVDs
Global Product Registration, QMS, Audit
ex: HSA, Biosensors
ASEAN-China & Singapore agencies advisors and committee, International speaker
Origin: Singapore, Malaysia, ASEAN
ARQon Team
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Biologics & Drugs
GMP, GLP, GDP, GDPMD
ex: HSA, GSK, Teva
Origin: US, Taiwan ROC, Singapore
Global Product Registration, ISO13485,
FDA, QMS
ex: Oculus (MR), Illumina
Origin: Singapore
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Regulatory & Quality Consultant
Diploma in Biomedical Engineering
Trish
Global Product Registration
Origin: Singapore, Philippines
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Regulatory & Quality Consultant
Diploma in Biomedical Engineering
Beatrice
Global Product Registration
Origin: Singapore
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Regulatory Affairs
Origin: Singapore
Senior Corporate Administrator
ARQon Singapore
Bing Kang
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HR Affairs
Origin: Singapore
Our Clients
What Our Clients Say
“ARQon has help AWAK achieve zero non-conformity during our ISO 13485: 2016 Quality Management Audit is not an easy feat to achieve. We like to thank them for their dedication and commitment in their work.”
“ARQon has help to complete the MDSAP gap analysis in a timely and professional manner and as a result we have reached a new milestone in achieving MDSAP certification effortlessly for MediPurpose.”
产品注册
牌照持有
额外的RA/QA支持
药物服务
健康安全
