ISO 13485

QUALITY SYSTEM MANAGEMENT FOR MEDICAL EQUIPMENT

Challenges in business

In the current context, there is a growing number of laws and stakeholders regarding medical equipment products. In order to meet the legal requirements and customer expectations, national regulatory authorities often make recommendations to manufacturers of medical devices that need to apply quality management systems. quality and is certified by a third party.
The application of a quality management system according to TCVN 13485: 2017 (ISO 13485:2016) standard will help businesses to demonstrate the ability to provide medical equipment and related services to meet customer requirements. and legal requirements.

HOW Bureau Veritas Certification Vietnam HELP YOU

With the experience of evaluating the quality management system for medical equipment, along with the understanding of assessors about the laws, the different requirements of the market, we will provide tailored solutions. suitable to the needs of each business
In addition, the application and certification of quality management systems according to TCVN 13485: 2017 (ISO 13485:2016) will also help businesses:

• Demonstrate capacity and declare eligibility to manufacture medical equipment as required by law
• Improve the competitive position with certification of an independent and reputable organization
• Enhance the value of the company's medical equipment products thanks to the reputation of a nationally and internationally recognized certification organization such as Bureau Veritas Certification Vietnam

HOW to get certified

• Determining scope of certification
• Preliminary assessment (optional): assisting enterprises with a comprehensive preliminary assessment of the system through the actual inspection process and reviewing documents on the quality management system of the business.
• Stage 1 certification audit: a physical assessment to determine whether an enterprise is eligible for certification or to analyze all necessary information about the business. We review documents of the company's quality management system according to TCVN 13485: 2017 (ISO 13485:2016) standards.
• Phase 2 certification review: actual inspection of the application of quality management systems at the business and the effectiveness of the system.
• Issue certification (after completing corrective actions, if any)