Before talking about ISO13485 certification, please think about what is the ISO13485 standard?
The ISO13485 standard is a quality management system standard applicable to medical device regulatory environments. Its full name is “Medical Device Quality Management System for Regulatory Requirements.”
It adopts the relevant concepts based on PDCA in the ISO9001 standard. Compared with the ISO9001 standard, which is applicable to all types of organizations, ISO13485 is more professional and focuses on the design and development, production, storage and circulation, installation, service and final decommissioning of medical devices. and disposal and other related industry organizations. Currently, organizations can establish systems or seek certification based on the ISO13485:2016 standard.
Key contents of ISO13485 standard
Taking regulatory requirements as the main line, it strengthens the main responsibility of enterprises to meet regulatory requirements;
A risk-based approach to management processes, reinforcing that the organization shall apply a risk-based approach to the appropriate processes required to control the quality management system;
Emphasis is placed on communication and reporting requirements with regulatory authorities;
On the basis of ISO9001, more emphasis is placed on the requirements for documentation and recording.
The main types of organizations involved in ISO13485 certification include: medical device designers and manufacturers, medical device operators, medical device service providers, medical device software and hardware developers, and medical device parts/material suppliers.
Related product ranges used for ISO13485 certification
Related products covered by ISO13485 certification are divided into 7 technical fields:
1. Non-active medical equipment
2. Active (non-implantable) medical devices
3. Active (implantable) medical devices
4. In vitro diagnostic medical devices
5. Sterilization methods of medical devices
6. Medical devices containing/using specific substances/technology
7. Medical device-related services
The significance of ISO13485 certification:
Raise and improve the management level of enterprises, avoid legal risks, and increase the visibility of enterprises.
Improve and ensure the quality level of products so that enterprises can obtain greater economic benefits.
Helps eliminate trade barriers and obtain a pass to enter the international market
It is helpful to enhance the competitiveness of products and increase the market share of products.
Through effective risk management, the risk of product quality accidents or adverse events can be effectively reduced.
Improve employees’ sense of responsibility, motivation and dedication.
We have passed ISO13485 certification, which can ensure the company’s management level and product quality. Please feel free to purchase.
Post time: Oct-18-2023