ISO 13485
What is ISO 13485 - The Medical Device Management System?
As a result of the nature and use of medical device products, the design, manufacture and distribution of all devices is highly regulated and needs to be stringently managed.
At each stage of a product’s life cycle, processes and practices are scrutinised against the 13485 standard and regulatory requirements (depending on the products and services in question).
These might include:
- Design
- Manufacture
- Assembly
- Testing
- Packaging
- Storage
- Delivery
- Any service stages
Each of the processes required to deliver products and services to your clients will need to be documented in a quality management system (QMS) in order to demonstrate regulatory compliance and best practice.
The benefits of ISO 13485
Adhering to ISO 13485 and implementing this standard not only enhances the credibility of your organisation, but also ensures that your products and services meet rigorous safety and effectiveness criteria, as well as:
- Your clients can be confident that products and services are safe and effective
- You can be confident you are conforming to regulatory requirements
- You can;
- Improve the way you manage risk
- Improve process efficiency
- Reduce costs
How can Statius help?
Statius can help with a number of aspects regarding the ongoing development and improvement of your ISO management systems.
We can become your internal ISO manager and do as much, or as little as you require, in order to assist with the ongoing development of your management system.
Click our link below to book a free consultation!
