As each project is rather unique, so the one-size-fits-all approach may not be good enough for your organization to reach the full potential. The auditors may be not satisfy to find out that your project is engaged with common approach to an uncommon situation. Therefore, we can help you to develop customized plans that are tailored in accordance with specific rules and regulations, conforming to industrial standard and international marketing requirements that achieving your delivery goal.

由于每个项目都非常独特,因此“一刀切”的方法可能不足以使您的组织充分发挥潜力。 审核员可能在发现您的项目采用了共同的方法来处理不常见的情况下不会满意。 因此,我们可以帮助您制定符合特定规则和法规的量身定制的计划,并符合实现交付目标的工业标准和国际营销要求。

由於每個項目都非常獨特,因此“全部都一樣”的方法可能不足以使您的組織充分發揮潛力。 審核員可能在發現您的項目採用了共同的方法來處理不常見的情況下不會滿意。 因此,我們可以幫助您制定符合特定規則和法規的量身定制的計劃,並符合實現交付目標的工業標準和國際營銷要求。​

Whether you want just a simple method to implement a minor correction or looking for the strategy to fix a major compliance issue, we can provide the consulting service either on an a-la-carte budget or supporting your corrective actions as a full packaged project.



who we are

our approach

we believe in a unique and customized consulting experience for each and every client.





Our team with a world of experience in manufacturing of medical devices and ancillary equipment, we offer consulting services from a user’s prospective and from the auditor’s viewpoint, to guide your project to an accomplishment level, satisfying the regulators demand and exceeding customers’ expectation.




New product design risk assessment

510(k) risk planning & reliability testing

Supply chain sourcing strategy & material management

Pre-fab risk & HACCP evaluation 

PFMEA root cause & process risk mitigation

Gap analysis failure investigation strategy

Quarantine & recall strategy

FDA/MDSAP pre-audit compliance assessment

FDA Form 483 & CAPA response with closing strategy

ISO 13485, 14001, & 45001 pre-cert evaluation

CE Mark application document development

Clinical trial & HIPAA compliance consultation

MDSAP, EU-MDR & NMPA consultation

Corporate sponsored 6-sigma Black Belt training