Trainings & Workshops
What We Offer
2regulatory requirements EEC– enforcement & implementation of regulations
2legal basis for manufacturers, users and operators
2quality management according to EN ISO 9001
2environmental management according to EN ISO 14001
2methods and tools of risk management
2the meaning of quality (workshop)
2preparation, performance & wrap-up of audits acc. to ISO 19011
2medical device consultant according to German MPG
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Trainings & Workshops
On request, we are pleased to offer you customized trainings according to you individual processes and needs. Supported by training experts we create tailored workshops to enhance the value and benefit of staff coming together. We are looking forward to your inquir.
Our Services
Just Blogging
Using an environmental management system generates significantly added value in case legal applicable safety at work requirements are defined as quality objectives...
Welcome to our new website!
The QC Loop team is creating a new approach on process-oriented control loops to ensure full compliance for medical device...
NEWS
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Following the first reading vote of the Parliament in April 2014 and a Council's informal position in October 2015, the Council and the Parliament agreed on a final text on 15 June 2016. At this moment in time, work is ongoing to translate the final texts in all the EU official languages and to correct technical inconsistencies. Final formal adoption is expected both on the Council and the Parliament sides during the first semester 2017. - http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_de
European Commission
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ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. - http://www.iso.org/iso/catalogue_detail?csnumber=59752
ISO org
