System Certification

Introduction to ISO13485 Certification 

The International Organization for Standardization (ISO) has developed over 17,000 international standards covering various fields. For medical device organizations, the most important of these standards is ISO13485, which provides the best practices for an internationally recognized quality management system (QMS) related to the medical device industry.

ISO13485, full name "Medical Devices - Quality Management System - Requirements for Regulatory Purposes", was developed by the ISO/TC210 - Medical Device Quality Management and General Requirements Standardization Technical Committee. This standard covers every aspect of the medical device life cycle, from product initiation, design and development, sample preparation, registration testing, clinical trials, product registration, production, sales, and use. Meeting ISO13485 enables manufacturers to clearly demonstrate their ability to provide medical device products that consistently meet customer requirements and applicable regulatory requirements, providing confidence for consumers and professionals.

The ISO13485 certification for medical device quality management system is an important foundation for medical devices to meet the requirements of most countries' relevant regulations, and it also reflects your commitment to meeting customer requirements. However, for most countries, for medical device manufacturers, merely meeting the ISO13485 standard is not sufficient to meet all regulatory requirements. They also need to obtain the corresponding regulatory certification certificates issued by the regulatory authorization institutions. For medical device subcontractors, component manufacturers, service providers, and medical device distributors, they usually only need to obtain the ISO13485 certificate.

Whether for brand holders, small manufacturers, or multinational enterprises, medical device certification is applicable to all. 

Obtaining ISO 13485 certification and maintaining compliance with the system 

The ISO 13485 standard is an effective solution for meeting the comprehensive requirements of the QMS. Obtaining ISO 13485 certification provides a practical basis for manufacturers to fulfill the commitments regarding medical device directives, regulations, and product safety and quality. 

The advantages of ISO 13485 certification 

ISO 13485 certification can help you enhance the overall quality system level, eliminate uncertainties and expand market opportunities. Obtaining this certification is the organization's commitment to quality for both customers and regulatory agencies. 

Overview of how to assess and improve processes 

Improve efficiency, reduce costs and monitor performance 

Prove that you produce safe medical devices 

Compliant with regulatory requirements and customer expectations 

ISO 13485:2016 has become the harmonized standard for the European Union.

The medical device quality management system standard ISO 13485:2016 has become the harmonized standard for the European Union's medical device directives: MDD, AIMDD and IVDD. The EU Official Journal has announced that EN ISO 13485:2016 officially replaces the previous version EN ISO 13485:2012. The "cease of presumption of conformity" date for EN ISO 13485:2012 is March 31, 2019. 

The EU harmonized standards are standards developed by recognized EU standard organizations (CEN / CENELEC / ETSI) at the request of the European Commission. These standards start with the letter "EN". Although harmonized standards are voluntary, they are the most recognized standards in the EU (state-of-the-art). Choosing EU harmonized standards is the best way and method to prove compliance with EU regulations. 

The release of the EN ISO 13485:2016 harmonized standard has further facilitated the integration of the standard with the MDR regulations and the IVDR regulations, enabling manufacturers to demonstrate compliance with the standard as evidence of meeting the requirements of the relevant regulations. The transition periods for MDR and IVDR are 3 years and 5 years respectively. 

Offer ISO 13485 and CE certification services 

ISO 13485 is the best internationally recognized model for medical device organizations to prove their compliance with the laws and regulations of the medical device industry. As a quality management system standard, ISO 13485 forms the basis for CE certification under the EU medical device directives and regulations. 

Although ISO 13485 certification is not a direct requirement for CE certification according to the EU Medical Devices Directive and Regulations, it has been recognized by the European Commission as a harmonized standard. As one of the leading notified bodies providing CE certification, we can assist you in choosing the most effective conformity assessment route for CE certification. 

ISO 13485 Certification Process 

I. Specific Content 

Step 1 - Provide customized suggestions based on the size and type of the organization. Once you sign the contract, the consultation process can commence. 

Step 2 - Offer optional "pre-audit" services tailored to the readiness level and weak points of the project. 

Step 3 - Formal Review. First stage: Preparation assessment: Evaluate the documented system and other important systems established by the organization, and identify non-compliance issues. 

Step 4 - Second Phase: This involves conducting interviews with staff, reviewing documents, and conducting on-site inspections of work practices. The audit findings will be presented. Once the audit is deemed合格， a certificate will be issued. 

Step 5 - According to the contract, conduct supervision and review of the implementation of the system and the rectification plan every half year or annually. 

Step 6 - After the three-year validity period of the certificate has expired, a re-certification audit will be conducted.