To sell medical devices in Australia, and most countries internationally, a business must demonstrate compliance with the requirements of ISO 13485 quality standard. ISO 13485 sets out the requirements for quality management systems in MedTech. The standard covers the design, development, manufacturing, distribution, storage, and installation of the device.
If you are manufacturing the product yourself, then all of the above processes need to be certified to the standard. However, most start-ups and medium-sized businesses outsource the various components of the product development process to expert suppliers, such as electronics designers and manufacturers.
If the contract designer or manufacturer is not certified, then you, the product owner, must audit the supplier which can be a long and laborious process. The process is simplified greatly if the contract manufacturer already has ISO 13485, as Circuitwise does.
Product development usually starts with ISO 13485 approved industrial and electronics designers, who supply the manufacturer with a package of schematics, components and instructions on build the device. The designers selected should have a close working relationship with an electronics manufacturer, who can address questions of manufacturability as they arise.
For the manufacture of the device itself, the main requirements relate to:
Documentation: The standard requires all the major processes and procedures be defined and to maintain records that demonstrate they are being followed. Manufacturers must document everything from initial customer requirements through to delivery of the final product, including all the management, production and monitoring processes below.
Management responsibility: The leadership of the manufacturer drive the quality system by establishing the required quality management systems and a quality-focused culture. Management systems include customer management, human resources, risk management, engineering, project management – and have review processes in place to maintain quality.
Production and service provision: The standard requires that manufacturing is planned, executed, monitored, and controlled – ensuring the delivered product meets customer specifications. Every aspect of the manufacturing process must be controlled from purchasing and materials management to process control and product testing.
Monitoring and measurement: Every part of the production process should have testing, measurement, analysis and monitoring in place to ensure the system is complying with standards and preventing defects. The standard requires that all equipment is calibrated and verified to ensure that the data is accurate. Systems need to be in place to handle non-conformities.
In order to maintain an effective quality management system, a good manufacturer will have in place a number of practical measures, including
An experienced engineering team in place to continually improve processes
An integrated software system to seamless move information to where it is needed and efficiently handle the necessary documentation
An effective risk management system to identify and address issues, such as component availability, before they impact delivery
First article inspection to ensure a production run is correctly set up before starting
Inspection systems for adherence to the Acceptable Quality Limit
Traceability systems for tracking where every component has come from and went to.
ISO 13495 is complicated, and the above points only touch the surface of what is involved. To find out more the following links are a good place to start.
You can purchase the standard from ISO and read through it
The Australian regulatory guidelines for medical devices outlines the regulatory requirements for manufacturing medical devices and provides a good context for why ISO 13485 is required.
The Therapeutic Goods Administration has a range of resources to help you get started on your medical device development journey