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Services

​Our services for medical devices

E-Learning

Effective auditsEffektive Audits

Consulting

​Time Management

E-Learning ​efficient and target-oriented

​Documentation for medical devices often appears complicated:
However, 80% of all tasks are identical and are repeated by many of our customers.


D​Through our e-learning area you turn your young employees into experts
and relieve yourself of training and guiding young colleagues.

​WE SUPPORT

​Sell your products without delay. With our team orientation and technical expertise we help you to achieve your goals.


​With the help of our templates you can efficiently and purposefully implement your project yourself.


​WE OFFER

  • ​Explanation of requirements
  • ​Guidance on implementation
  • ​templates - checklists - infographics
  • ​many insights from many years of consulting practice
  • ​Experience from many different projects
  • ​"Dos and dont's" - What you should and shouldn't do

​You will receive all this information in the course in the form of videos, texts, graphics and templates


​Effective audits ​through preparation & support

​Many manufacturers need support especially before and after audits by a notified body or authority.

​​The preparation and follow-up of an audit:

​​Especially the tasks before and after audits accumulate in short periods of time.

​The resulting stress and workload in the responsible teams often lead to mistakes, which in turn generate more work.

​​How we support you:

​In these phases we can optimally step in for you as external reinforcement


  • ​We can absorb work peaks
  • ​We work on a subject area on request
  • ​Support for overworked teams as interim colleagues
  • ​We can also offer comprehensive support before, during and after the audit
  • ​As a reviewer, sparring partner or mock auditor we help you with the preparation
  • ​We perform internal audits
  • ​We perform supplier audits

​Personal consulting ​in your company

​​We offer a variety of purely digital solutions. In addition to our online courses, we execute many tasks from our offices. Many arrangements are now done purely digitally using various solutions such as Zoom, Microsoft Teams, WebEx and others.

​​So you don't need more resources, and collaboration is possible even when offices are full or computers are not available.

​Nevertheless, in some cases personal advice and support on site is not replaceable.

CONSULTING - ​REMOTE OR ON SITE WITH YOU

​Whether you need a usability engineering file according to the latest standard or a revision or review of individual documents.

We will support you in these tasks.


​Do you need to evaluate or understand a certain topic?
​You need a discussion partner for a topic?
​You would like to make your mark in the company or recommend for the next promotion, but are not quite sure about a topic or need selective support?


​As a consultant, we take on tasks that you cannot take on in terms of time or expertise.
​We support you to the extent and according to the processes you need - if required, also very discreetly.

​SPECIAL EXPERTISE

​Engineers (Dipl.-Ing.) in electrical engineering with many years of development and project experience in medical technology provide you with specialist support, particularly in

  • ​devices as medical devices
  • ​Medical devices with or as software
  • ​Tool validation
  • ​Risk Management
  • Usability Engineering
  • ​Electrical safety / EMC
  • ​Creation or revision of the technical documentation

​Time Management - ​simply more time

​Shorten the time needed to implement standards, directives and laws.

​TIME MANAGEMENT AND COSTS

​Save yourself the usual additional costs of a permanent position.

​Simply book the expertise you need when you need it.

​Or get assistance for a change of plan, or before an important milestone.


​​In all these cases we support you as external experts

​THE COST-EFFECTIVE SHORTCUT

​We are a team of experts.

​Therefore, we have already implemented many of the tasks that arise for manufacturers of medical devices several times and under different conditions.

​In some areas we already know what is to come through our expert work in committees and commissions.


​You can book us flexibly according to your needs.

​For the scope and thus also the costs that you can specify and plan.


​This enables us to find the most favourable way of implementation for you.

​Or simply to support your team efficiently in the implementation.

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