Won-Med - ISO certification organization, CE Marking and FDA registration

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ISO CERTIFICATION CONSULTING

ISO 27001 Certification Consulting

ISO 27001 Certification Consulting

ISO/IEC 27001 is the leading international standard for information security management.

The ISO 27001 standard helps businesses protect confidential, important information assets.

Won-Med is an ISO 27001 certification consulting organization according to international standards.

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ISO 45001 Certification Consulting

ISO 45001 Certification Consulting

ISO 45001:2018 (replacing OHSAS 18001) is the international standard for Occupational Health and Safety Management Systems.

Applying ISO 45001:2018 helps confirm compliance with occupational health and safety policies.

Building this system helps businesses manage risks in occupational safety and health for employees.

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ISO 14001 Certification Consulting

ISO 14001 Certification Consulting

ISO 14001:2015 is a standard of the international organization for standardization ISO issued on September 14, 2015.

ISO 14001:2015 is an Environmental Management System – Includes detailed requirements and instructions for use.

ISO 14001 is beneficial for any organization to improve and manage resources more efficiently.

To achieve ISO 14001 certification or contact us for specific advice and support.

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ISO 22000 Certification Consulting

ISO 22000 Certification Consulting

ISO 22000 is an internationally recognized Food Safety Management System standard.

Is a clear proof that the company's products meet the quality and safety of international standards.

ISO 22000 standard applies to all types of food production and business enterprises.

The process of applying and certifying ISO 22000 through many processes, it is necessary to have a certification consulting organization to support the implementation.

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ISO 13485 Certification Consulting

ISO 13485 Certification Consulting

ISO 13485 is an international set of standards for quality and safety management systems for medical products.

All medical device manufacturers, before putting their products on the market, must obtain ISO 13485 certification according to Vietnamese regulations.

This is an internationally recognized medical device quality management system and the new version of ISO 13485 is ISO 13485:2016.

To get ISO 13485 certification, businesses must be consulted and guided in detail on the most appropriate steps.

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ISO 9001 Certification Consulting

ISO 9001 Certification Consulting

ISO 9001 is an international standard for Quality Management Systems published by the International Organization for Standardization (ISO).

The latest version of this standard is ISO 9001:2015, which is globally accepted and valid.

The form of ISO 9001 consulting is implemented with 2 specific goals:

- Consulting on awareness, application and implementation of ISO 9001 quality management system standards:

- ISO 9001 certification consulting - ISO 9001 certification goals.

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CE MARKING CERTIFICATION

CE Marking 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.

Contact Hotline or send information to receive the DETAILED PRICE LIST for CE Marking and RELATED SPECIFIC PROCEDURES CE Certification.

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CE Marking Directives

CE Marking Directives

There are 23 product groups that are required to comply with the European standard directive CE Marking before entering the European market..

The CE regulation and directive means 'Compliance with European Standards for Products' according to a particular group.

CE certification is a standard regulation of the European Union (EU), which is allowed to circulate on the EU market.

CE certification is the "commercial passport" of products, opening up export opportunities to the EU market.

Won-Med provides CE certification services for businesses in Vietnam exporting to Europe.

Contact Hotline or send information to receive DETAILS PRICE LIST, SPECIFIC PROCEDURES FOR CE CERTIFICATION.

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CE Certification for Medical Device

CE Certification for Medical Device

CE stands for Conformité Européenne, which means 'Conforming to European Standards'.

The CE mark is a quality certification of the European Union (EU), which is allowed to be sold on the EU market.

CE certification is the "commercial passport" of products when imported into the European market.

Won-Med is a comprehensive certification body CE Marking for all products according to European Commission regulations.

Contact Hotline or send information to receive DETAILS PRICE LIST and SPECIFIC PROCEDURES CE CERTIFICATE.

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FDA REGISTRATION

US FDA registration

US FDA registration

FDA is an acronym for Food and Drug Administration.

FDA is a division of the United States Department of Health and Human Services, headquartered in Washington DC.

FDA registration is a very important registration when businesses want to send or export goods to the US market.

Food, medical products, cosmetics... require FDA Certificate when imported into the US.

Won-Med is an organization that provides FDA registration, Product Notice 510K service for businesses exporting to the United States.

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Product notification service 510K

Product notification service 510K

FDA 510k (FDA's Premarket Notification 510(k)) – Notice before the product is put on the US market.

FDA is an acronym for Food and Drug Administration.

Product notice (FDA 510K) is a very important document when businesses want to send or export goods to the US market.

Won-Med is an organization that provides FDA 510K product notification service to businesses exporting to the United States.

Contact Hotline or send information to receive DETAILS PRICE LIST, RELATED SPECIFIC PROCEDURES FDA 510k.

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PMA product publication service.

PMA product publication service.

PMA is the FDA's regulatory and scientific review process to evaluate the safety and effectiveness of Class III medical devices.

Product Disclosure (FDA PMA) is extremely complicated, to better understand please contact Won-Med for advice on PMA registration.

FDA is an acronym for Food and Drug Administration.

FDA PMA is a very important Product Disclosure Paper when bringing Class III Medical Device products to the US market.

Class III medical devices are required to have an FDA PMA Product Declaration when circulating in the US market.

Won-Med is an organization providing FDA PMA product registration registration service for businesses in Vietnam.

Contact Hotline or send information to receive DETAILS PRICE LIST, PMA RELATED SPECIFIC PROCEDURES.

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RELATED SERVICES

HACCP Certification

HACCP Certification

HACCP - stands for Hazard Analysis and Critical Control Points.

Is Hazard Analysis and Critical Control Points.

It covers the principles used in establishing a food safety management system.

For food manufacturers, this is a mandatory requirement before putting products on the market.

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Product Certification

Product Certification

To put commercial products or goods on the market.

Enterprises need to carry out product quality certification before circulating goods.

Won-Med provides product certification services for all groups of products that are circulated in accordance with industry and trade regulations.

Support all application procedures, and guide in detail procedures, shortening the certification time in the fastest way.

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KS Certification

KS Certification

KS CERTIFICATE - Korean industry standard.

KS is a national standard based mainly on the Korean Industrial Standards Act..

If you pass all KS certification factory inspection and product test, KS certificate will be issued.

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RELATED INFORMATION

Exporting masks to the US market

  • Mô tả

    Vietnamese enterprises exporting face masks to the US market need to go through many processes and register the necessary procedures to be able to export.

  • Exporting pepper to the US

  • Mô tả

    Vietnam's pepper market share in total US imports increased from 66.6% in 11 months of 2020 to 68.25% in 11 months of 2021.

  • Exporting Coffee to the US

  • Mô tả

    US coffee imports reached 1.35 million tons, worth 5.72 billion USD, up 5.2% in volume and 19.7% in value over the same period in 2020.

  • Exporting Cashew Nuts to the US

  • Mô tả

    Vietnam's cashew nut market share in total US imports. November 2020 was 89.64% and decreased to 89.35% in 11 months of 2021.

  • Regulations for export to the US

  • Mô tả

    Specific regulations for each product group of US Customs for direct export to the US.

  • Won-Med Information Privacy Policy

  • Mô tả

    Information security policy and compliance with security regulations, commitment to use customer information through web and internet systems.

  • Read more >>

    CONSULTING - INTERNATIONAL CERTIFICATE

    WON-MED 

    Head Office in Korea: Rm512, Hanshin IT Tower, 272, Digital-ro, Guro-gu, Seoul, Republic of Korea.
    Contact in Viet Nam: P7-43.OT09, Park 7, Vinhomes Central Park, 720A Dien Bien Phu St, Binh Thanh District, Ho Chi Minh City.

    Tel: +84 (0) 283 620 6200 - Hotline: 0325269326.

    Email: [email protected]

    Website: wonmed.net

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