Training
ISO 13485 Training
Training managers, department heads, medical device quality experts with knowledge of quality management systems and ISO 13485:2016.
ISO 9001 training
Awareness of ISO 9001 is an extremely important knowledge base.
Won-Med provides auditor training, awareness training and ISO 9001 implementation.
Businesses that need to be equipped with knowledge and awareness about ISO 9001, please contact us for specific advice.
ISO 14001 Training
Training experts to assess ISO 14001 Environmental Management System.
Participants are ISO experts, individuals, managers, manufacturers of organizations and businesses.
Won-Med provides training services and issues ISO training certificates with international value.
RELATED INFORMATION
Regulation (EU) 2017/746 for Medical Device
Amendment to Regulation (EU) 2017/746 concerning transitional provisions for certain in vitro diagnostic medical devices and the deferment of the application of conditions for internal devices.
Medical Device Directive EU 2017/745
MDR 2017/745 has a total of 10 chapters with 123 articles, 17 appendices. (while MDD 93/42/EEC has 23 articles and 12 annexes).
Low voltage directive (lvd) EC:2014/35/EU
The Low Voltage (LVD) Directive EC: 2014/35/EU provides a high level of protection for European citizens within certain voltage limits and applies to the European market and elsewhere in the world
What is ISO 14001?
The ISO 14000 family of standards has many standards of which ISO 14001 is the central standard.
Machinery Directive EC:2006/43/EC
On 17 May 2006 the European Commission issued the latest Machinery Directive (2006/42/EC).
Export of medical equipment to Europe
Which medical equipment and personal protective equipment need CЄ Marking certification to be eligible for export to the European market? What is the process, procedure, and cost to get the COR certificate?
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