In-house competence…

 

Sometimes it surely is worthwhile to develop your own competence instead of buying it. consulting & more a broad training portfolio according to this topic. Place, time and procedure are of course flexible parameters, which we fully crop on your needs.

 

Topics for training

 


One of the most often heard questions is: What are Your next planned training events?

It is possible to join in consulting & more trainings organized in cooperation with different academies. The information about this training events can be found on the home pages and the marketing material of these partner companies. If You need further information or additional questions, please contact us per mail.

Most effective is a training especially organized for You taking only Your needs and wishes into consideration. These so called In-House-Trainings can be organized especially according to the needed topics, depth and time planning of Your company. Normally this kind of training is profitable for You with a number of four participants!

Examples for training events


R&D and the documentation of Medical Devices and IvD Devices (2 days)
Requirements to the Design Documentation of Medical Devices
Design Procedures and their validity
Workshops for practical exercises in Device Documentation for simple examples.

MDD and IvDD for distribution and field service (1 day)
Definition Medical Device, IvD, European and national legislation
Rights and duties of distribution and service personell
Reporting duties and deadlines, information provided by distribution and service personell

Risk Management for Medical Devices and IvD Devices (1 day)
The harmonized standard EN ISO 14971
Requirements, procedures and responsibilities
Realization of Risk Management with an example device (Workshop)

Technical Product File and Instruction for Use (1 day)
Which data is really needed for the Technical File acc. to MDD / IvDD and FDA?
Risk Management as essential part of the Technical File
Instructions for Use as Output of Risk Management

Biological Agents Directive in the daily work (Directive 2000/54/EC) (1 Tag)
Who should work in accordance with the directive?
Which medical Doctor and which manufacturer has to fulfil the requirements?
How to realize the needed processual Risk Management?
Concept for realization (Workshop)

Basics of Hygiene for the daily Business (1 day)
Why Hygiene measurements should be taken and who is taking advantage of this?
Processual and structural measurements and responsibility
Examples from reality to practice

The medical Doctors office as service organization (1 day)
Who is part of the service organization - who is the customer?
The Doctors Quality Policy as advantage in commercial competition
Increasing of healing rate by raising up the customer satisfaction

You need other topics? You want to change the main emphasis of a Training? Quality Management should be stressed more? consulting & more will discuss all Your needs with You to create a training just as You need it. Even the rooms, conference technique and other trainers can be organized on Your demand.

Please contact us per mail for further information.