ISO CERTIFICATION
ISO 45001:2018 Certification
Issuing ISO 45001:2018 certification.
Occupational Health and Safety Management System.
With international value, granted by the world's leading prestigious organization.
Guided and evaluated by international experts of leading organizations.
ISO 27001:2013 Certification
Issuing ISO 27001:2013 certification.
Information Security Management System (ISMS).
With international value, granted by the world's leading prestigious organization.
Guided and evaluated by international experts of leading organizations.
ISO 22000:2018 Certification
Issuing ISO 22000:2018 certification.
Food Safety Management System.
With international value, granted by the world's leading prestigious organization.
Guided and evaluated by international experts of leading organizations.
ISO 9001:2015 Certification
Issuing ISO 9001:2015 certification.
Quality management system.
With international value, granted by the world's leading prestigious organization.
Guided and evaluated by international experts of leading organizations.
ISO 13485:2016 Certification
Issuing ISO 13485:2016 certification.
Medical Device Quality Management System.
With international value, granted by the world's leading prestigious organization.
Guided and evaluated by international experts of leading organizations.
ISO 14001:2015 Certification
Issuing ISO 14001:2015 certification.
Environmental management system.
With international value, granted by the world's leading prestigious organization.
Guided and evaluated by international experts of leading organizations.
CE CERTIFICATION
CE Marking Certification
CE stands for Conformité Européenne, which means 'Conforming to European Standards'. The full name is CE Marking.
CE Marking is a safety directive of the European Union (EU), products with CE Marking are allowed to be sold on the European market.
CE Marking certification is the "commercial passport" of products when entering Europe, opening up huge export opportunities for businesses.
Won-Med is a comprehensive certification body CE Marking for all products according to European Commission regulations.
CE Certification for Medical Device
CE stands for Conformité Européenne, which means 'European Standards Compliant'
CE certification is a quality certification of the European Union (EU), which is allowed to circulate on the EU market.
CE certification is a "commercial passport" when the product is officially sold in the European market.
Won-Med is an organizion to provide comprehensive certification services CE Marking for all products according to European Commission regulations.
CE Marking directives
There are 23 group products with 23 CE Directives, different directives apply depending on the product.
In each directive will specify the CE standards for each product.
Won-Med provides CE certification services for businesses in Vietnam exporting to Europe.
TRAINING
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.
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.
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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