ISO 13485 Certification- ISO 13485 Certificate in Vietnam. Introducing the ISO 13485 certification process, Procedures for registering quotes for ISO 13485 certification service.

ISO 13485:2016 Certification – Quality Management System for Medical Devices – EU Accreditation
Certification objectives and benefits of ISO 13485:2016
ISO 13485 is an International Organization for Standardization (ISO) standard first published in 1996. It specifies comprehensive quality management system requirements for the design and manufacture of medical devices, and is often required for legal and regulatory purposes.
VINTECOM International’s ISO 13485 certification services aim to promote the implementation and application of a quality management system that meets regulatory requirements as part of corporate management responsibility. Examples of market-specific requirements include 21 CFR 820 (Quality System Regulation for medical devices marketed in the United States, enforced by the U.S. Food and Drug Administration – FDA), and Directive 93/42/EEC (CE Marking) for medical devices sold in the European Union.
VINTECOM International provides ISO 13485 certification support for medical device manufacturers to ensure that:
+ Workplace controls are in place to ensure product safety, focusing on risk management and design control during product development.
+ Specific requirements for inspection and traceability are applied to implantable devices.
+ Specific documentation and validation requirements are met for sterile medical devices.
+ Specific verification is carried out to confirm the effectiveness of corrective and preventive actions.
To meet these requirements, ISO 13485:2016 certification services with EU accreditation provide medical device manufacturers with an independent audit and accreditation of their quality management system against ISO 13485:2016. This certification, accompanied by the European Union (EU) accreditation mark, assures that products and processes comply with international quality and safety requirements, while meeting the EU’s stringent regulatory and market standards.
Specific objectives of ISO 13485:2016 certification with EU accreditation
1. Evaluate compliance with ISO 13485:2016
+ Ensure that the company’s quality management system fully meets ISO 13485:2016 requirements, including quality control, design and development, production, inspection, and maintenance of medical devices.
+ Assess processes from production through product distribution to ensure all manufactured devices are safe and of high quality.
2. Ensure recognition and export capability to the EU market
+ Provide ISO 13485:2016 certification with EU accreditation to enable access and export of medical devices to EU markets, which have strict quality and safety requirements.
+ Ensure products meet the EU’s legal standards and safety requirements—critical for increasing international competitiveness.
3. Enhance product quality and reliability
+ Help organizations improve processes and quality management systems to ensure that medical devices are manufactured and tested to the highest quality standards, guaranteeing user safety and effectiveness.
+ Ensure all products are designed, developed, and manufactured in environments that strictly comply with quality and safety requirements.
4. Comply with global legal and regulatory requirements
+ Assist companies in meeting EU and international regulatory requirements for medical devices, minimizing the risk of legal violations and non-compliance costs.
+ Ensure products comply with international quality standards and the requirements of health authorities worldwide.
5. Improve credibility and customer trust
+ ISO 13485:2016 certification with EU accreditation enhances business credibility, increasing trust from customers and partners in using the company’s medical devices.
+ Provide assurance to customers that products are manufactured and tested under stringent quality and safety procedures.
6. Increase transparency and accountability
+ Help companies establish a transparent system for managing medical device quality, building trust and confidence within the community and among healthcare industry partners.
+ Ensure that all processes and products are continually monitored to maintain high quality and protect public health.

7. Enhancing Competitiveness and Expanding Market Reach
+ ISO 13485:2016 certification enables businesses to strengthen their competitiveness in the medical device industry, expand cooperation opportunities with international partners, and increase market share in regions requiring high-quality standards such as the EU.
+ Ensures that businesses can participate in major projects and international contracts within the healthcare sector.
+ Benefits of Using the ISO 13485:2016 Certification Assessment Service with EU Accreditation:
+ International Certification with EU Recognition: This certification facilitates the export of medical devices to EU and international markets, helping businesses easily meet strict regulatory requirements.
+ Improved Product Quality: Ensures that a company’s medical devices always meet the highest quality standards in line with international requirements and safety regulations.
+ Legal Compliance: Helps businesses fully comply with medical device regulations in different countries and regions, reducing legal risks.
+ Enhanced Reputation and Trust: ISO 13485:2016 certification with EU accreditation strengthens the company’s credibility, especially in the eyes of customers and international partners.
+ Market Expansion and Greater Competitiveness: Provides access to markets that demand high-quality, safe products, thereby increasing competitiveness and expanding global business opportunities.
+ Optimized Quality Management Processes: Helps companies improve production and inspection processes, minimizing product defects and increasing operational efficiency.
The ISO 13485:2016 certification assessment service with EU accreditation supports organizations in the medical device manufacturing sector not only in ensuring product quality but also in enhancing their reputation, competitiveness, and global business opportunities.
Maintaining valid ISO 13485 certification is often considered the first step toward complying with European regulatory requirements. Compliance of Medical Devices and In Vitro Diagnostic Medical Devices with the European Union Directives 93/42/EEC, 90/385/EEC, and 98/79/EEC must be assessed before they can be legally sold.
VINTECOM International supports companies in achieving ISO 13485 certification and assists them in demonstrating compliance, making it easier to “register” for the necessary licenses to manufacture and distribute. For medical devices that require prior approval before being placed on the market, the relevant conformity certificate allows CE marking and authorizes sales within the European Union. Quality Management System (QMS) assessments can be conducted in coordination with CE authorities, alongside the review of required technical documentation—an essential factor considered by Notified Bodies when issuing product compliance certificates.
This standard has been adopted by CEN as EN ISO 13485:2016 and harmonized under the European Medical Device Directive 93/42/EEC.
✅ Investing in a professionally implemented ISO system with EU/UKAS certification is an investment in your company’s future – helping you avoid missed opportunities caused by insufficient cost analysis and poor management of visible/hidden costs, by measuring process data, performing root cause analysis, and identifying losses from hidden expenses.
➡️ Contact us today for consultation and ISO certification services (ISO 13485, ISO 9001:2015, ISO 14001:2015, ISO 45001:2018) with EU/UKAS recognition.
If your organization requires consulting services for medical quality management system certification according to ISO 13485:2016, please click “Register – Get a Quote” or use the toolbar at the bottom right of your PC screen to receive a quotation for this certification consulting service.

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