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Workshop and Training

What is MyKaizhen workshop?


This is definition of workshop is

moderated working groups whose aim is to find solutions to problems, work on topics or promote the development of new ideas and innovations.


The typical event in medtech is training, seminar or webinar with defined topic.

Compared to training, MyKaizhen workshop focus on:

  • Interaction of participants

  • Communication in complex project

  • Cooperation of professionals between interdisciplinary departments, entities or even international parties

  • Customer tailored to find scenarios of risk-based solution

Type of Mykaizhen workshop


Firstly we want to underscore that no limit of Mykaizhen workshop was defined. We always try to find optimised solution for YOU. Very often customer comes with wished topics. We try to moderate with our compliance knowledge and international experience. It could be that we organise a JOINT WORKSHOP with our partners upon your agreements.

In the daily work in Medtech there are many intransparent troubles which are ignored because there is no process internally or no CAPA or finding is written by notified body or authorities. Exact these troubles or plans are critical for company’s success.


Here are some most asked workshops:

  • Regulatory Affairs: agile registration and effect communication

  • Lean in compliance for ALL professionals in interface to technical documentation

  • Quality management: international compliance

  • Product management and Sales/Marketing: prioritised market launch with partners

  • From Design and development to Production: Traceability is key

  • Intercultural communication: how to talk with different internal and external professionals?

  • International business: project management with controlling outweighs project plan

Typical training besides workshop in Medtech


As compliance experts we are specialised to provide training onsite and remote. Here are our typical trainings:

  • Chinese registration of medical device and IVD

  • From MDR to Chinese registration

  • From FDA to Chinese registration

  • From FDA to MDR and conversely

  • International market access with prioritization

  • Keep regulatory KPI in mind

  • Design control: Testing for registration and change assessment for next generation


Why chose US?


Our MyKaizhen workshop and training is primary personal meetup in and around GSA region (Germany, Switzerland and Austria). Exceptionally we could be delegated to your company outside Europe as weel.

The language could be chosen as English or German.


Due to our experience of compliance the focus of our workshop and training are mainly in medtech branch.


There are our unique advantages:

  • Free consulting in first 45 Min

  • Participants achieving own tactic to improve work efficiency

  • Groups with more exciting teambuilding

  • Time- and budget saving

  • Always kick off meeting to understand each other

  • Meeting protocol with action plans

  • Controlling of meeting result

  • Combined beneficial compliance programs as eLearning, MyTemplate or Flat Rate Compliance

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