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.

我们的团队在医疗设备和辅助设备的制造方面拥有丰富的经验,我们从用户的角度和审计人员的角度提供咨询服务,以将您的项目引导到成就水平,满足监管机构的要求并超出客户的期望。

我們的團隊在醫療設備和輔助設備的製造方面擁有豐富的經驗,我們從用戶的角度和審計人員的角度提供諮詢服務,以將您的項目引導到成就水平,滿足監管機構的要求並超出客戶的期望。


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





our approach

who we are

GMPSIGMA

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AREAS OF EXPERTISE

QUALITY & RISK MANAGEMENT COMPLIANCE Consulting

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.

无论您是只希望采用一种简单的方法来实施较小的更正,还是希望找到解决重大合规性问题的策略,我们都可以按预算提供咨询服务,也可以为您的整改项目提供支持。

無論您是只希望採用一種簡單的方法來實施較小的更正,還是希望找到解決重大合規性問題的策略,我們都可以按單項預算提供諮詢服務,也可以為您的整改項目提供支持。



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