Medkaizhen
Medkaizhen is combination of Medtech and Kaizen (continuous improvement). We strive for intelligent improvement of product development, quality management and regulatory affairs in field of medical device and In vitro diagnostics with best compliance.
The compliant and strategic plan and communication are the key of agile and sustainable success through interdisciplinary and international environment.
We engage ourselves from CE marking (MDR) to US (FDA), global registration in China and some critical markets to accelerate efficient product registration. Besides it, we have a unique academy where man can gain regulatory knowledge in one to one coach.
How we work
01.Technical documentation
Technical documentation is a showcase of medical device and In vitro diagnostics for international authority. It should show safety and effectiveness with stipulated evidence.
It is art to have a multi-market targeted technical documentation fulfilling country specific requirement.Eco-Friendly Design
02. Quality management
Quality management is a tool not only for certification, but more to be lived controlling the quality of medical device and In vitro diagnostics. It should be established, documented, implemented, maintained, updated and improved. Either change control, CAPA or vigilance, an improved procedure should be always optimized.
03. International market access
Knowing international regulations matters because it directly influence the global registration. We speak all mother languages in critical markets with local teams.
04. Interim manager
We are here to support all kinds of project from product development, product release, quality management to regulatory affairs. We believe that with cross department knowledges, the project is mastered. We send perfect interim project manager for small and medium-sized enterprises.d
Professionals
05.Regulatory academy
We update regulatory article from best practice. Any interested party anytime could join our one year academy or on-demand workshops on tailored topics. The coach is ready for case study and exchange.
If manufacturer needs trainings in Chinese regulation, regulatory LEAN or international project, we can organize remote or in-house training.
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