ISO 13485 Medical Device Management System

The gold standard of the global medical device industry

ISO13485 "Quality Management Systems for Medical Devices - Requirements for Regulatory Purposes" is an independent quality management system standard specifically designed for the medical device industry, published by the International Organization for Standardization (ISO). The current version of this standard is ISO13485:2016, and its core objective is to establish a systematic quality management process to ensure the safety and effectiveness of medical device products throughout their entire lifecycle, while meeting the compliance requirements of global medical device regulations. 
Applicable objects include: 
Medical device manufacturers (covering Class I, II, III products) 
Sterilization service provider 
Raw Material Supplier 
Distributors and Importers 
Clinical research institutions 
Software as a Medical Device (SaMD) Developer

1. Regulatory led quality framework 
Different from the universality requirements of ISO9001, ISO13485 emphasizes deep integration with medical device regulations and requires enterprises to establish: 
• Regulatory identification and update mechanisms (such as FDA 21 CFR Part 820, EU MDR/IVDR) 
• Product registration file management system 
• Post Market Supervision (PMS) System 
• Alert system and adverse event reporting process 

2. Risk management runs through the entire lifecycle 
Based on the requirements of ISO14971 standard, enterprises need to establish: 
• Risk management document for product design and development phase 
• Production process risk control matrix 
• Post listing risk reassessment procedure 
• Application of risk/return analysis tools 

3. Strengthen traceability management 
Implement UDI (Unique Device Identification) system and establish a traceability chain covering the following elements: 
• Raw material batch traceability 
• Production process parameter recording 
• Sterilization batch number management 
• Distribution channel tracking 
• Customer feedback on usage information 

4. Verification of Special Processes 
For key processes such as sterilization, cleanroom operations, and software validation: 
• IQ/OQ/PQ verification process 
• Statistical Process Control (SPC) 
• Annual revalidation plan 
• Change control management

For enterprises: 
• Reduce product recall risk (statistics show a 42% reduction in quality accidents) 
• Shorten the product launch cycle (accelerate registration approval by an average of 30%) 
• Achieve global market access (covering over 120 countries including EU CE, US FDA, etc.) 

For the industry: 
• Enhance the reliability of the medical device supply chain 
• Promote technological innovation and industrial upgrading 
• Establish internationally recognized quality standards

（I.） List of Application Materials 
Core documents:

Auxiliary materials: 
Enterprise business license and production/operation license; 
Organizational chart and job responsibilities description; 
Equipment list and calibration certificate; 
Employee training plan and assessment records. 

（II.） Application requirements 
1. Qualification requirements for enterprises 
Legitimate registered medical device related enterprises (manufacturers, suppliers, service providers, etc.); 
The product scope is clear and meets the definition of medical devices (including software, i.e. medical device SaMD). 

2. Operation of Quality Management System 
We have established a quality management system that complies with the ISO13485 standard and has been in operation for at least 3 months; 
Complete complete internal audits and management reviews, and retain relevant records. 

3. Compliance with regulations 
Identify and comply with medical device regulations in the target market (such as EU MDR/IVDR, US FDA QSR); 
Having product registration or filing qualifications (such as CE certificate FDA 510(k)）。 

4. Risk management 
Establish a full lifecycle risk management process based on ISO14971 and generate documented evidence. 

5. Traceability 
Realize full traceability of products from raw materials to end users (subject to UDI requirements).

The certification process for ISO 13485 medical device quality management system usually follows the following core steps, mainly focusing on establishing, implementing, auditing, and maintaining the system: