Chinese talent pool in medtech


As headquarter in Germany and diverse representative offices internationally we experienced different role as interim manager in Chinese projects for manufacturers of medical device.


The benefit of Chinese interim manager is that manufacturer could overcome temporary shortage of expertise. We as in figures below have full talents of RA/QA expertise.


Besides it, we are in geography flexible around Germany (also other EU-countries) and in China.


We can:

  • Speak German, English and Chinese
  • Prepare (edit), compile and release registration dossier
  • Be ordered using best practise selection from some hours till 25 hours per week
  • Onsite usually once weekly onsite as in German/Australia/Swiss/French/Italy firm

RA manager at manufacturer

I accompany normally typical registration project of class I to III medical device in China.

With my expertise you have better understanding of PTR, Type testing and reply deficiency quickly.


KPI: Chinese requirement, technical documentation

Outsourced RA manager for Chinese partner (distributor)

Using my marketing and regulatory knowledge I support Chinese distributor so solve all regulatory questiones as laision to overseas manufacturer.

Besdies I edit post market - and vigilance report in Chinese and German(English).


KPI: outsourced knowhow, Chinese agent

QM manager

I know ISO 13485 and Chinese GMP.

In one recent project I asisst to establish Chinese plant for foreign manufacturer and receives GMP certification in Shanghai.


KPI: Quality management system, design transfer, outsourced production

Project manager

In a not smooth running project between many parties in US, France and China, I try to make transparent time - and conflict managment to complete project compliant with Chinese regulation.


KPI: Lean, project management

Lead manager

I started a training regularly in a medtech in Swiss. The colleague could make own Chinese registration.

Besides it, I can support all strategic meeting in Chinese and international registration of medical device.


KPI: regulatory LEAD, tactic

Allrounder

Based on trouble and inquiry, our strongest support is as a team.


We will provide solution and senarios of challenging questions.