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 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
ISO 13485 Certification the promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U.S. Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union.
ISO 13485 certification for factory as below:
-controls in the work environment to ensure product safety
-focus on risk management activities and design control activities during product development
-specific requirements for inspection and traceability for implantable devices
-specific requirements for documentation and validation of processes for sterile medical devices
-specific requirements for verification of the effectiveness of corrective and preventive actions
Compliance and certification with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Directives 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. One of the major requirements to prove conformity is the implementation of the Quality Management System according ISO 9001 and/or ISO 13485 and ISO 14971.
For those medical devices requiring the pre-market involvement of a Notified Body, the result of a positive assessment from the Notified Body is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union. A very careful assessment of the company Quality Management System by the Notified Body, together with the review of the required Technical Documentation, is a major element which the Notified Body takes into account to issue the certificate of conformity to the company product(s).
This standard adopted by CEN as EN ISO 13485:2016 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC.

Organizations and enterprises desire register of certification ISO 13485, please contact:

📶📶📶 Contact us to register for ISO 13485 certification.

Customers, organizations and enterprises require ISO 13485 Certification services, please click on "Registration - Quotation" or on the right toolbar below the PC screen to receive a quotation for training, consulting and certification services.

📶📶📶 Further information, please contact us as below:

🌐 VINTECOM International Office in Ha Noi City: 16th Floor - Green Stars City, 234 Pham Van Dong, Bac Tu Liem District, Ha Noi City. Hotline 094-886-5288/ (024) 730-588-58

🌐 VINTECOM International Office in Ho Chi Minh City: Golden City House - 182 Ha Huy Giap, 12 District, Ho Chi Minh City. Hotline 0938-083-998/ (028) 7300-7588

VINTECOM INTERNATIONAL MANAGEMENT CONSULTANCY COMPANY

Head Office: No. 5 Hoang Sam treet, Nghia Do, Cau Giay district, Ha noi City

VINTECOM HN OFFICE

Address: 16th Floor - Green Stars City

234 Pham Van Dong Street, Bac Tu Liem District, Ha noi City

Tel : (024) 730.588.58/ (024) 730.333.86

Hotline: 094 886 5288

Skype: kd.vintecom

Email : office-hn@vintecom.com.vn

Web : www.vintecom.com.vn

VINTECOM HCM OFFICE

Address : Golden City House