What are the requirements of ISO 13485 certification for electric wheelchair manufacturers?

What are the requirements of ISO 13485 certification for electric wheelchair manufacturers?

ISO 13485 certification is a quality management system standard for the medical device industry. Electric wheelchair manufacturers must meet the following requirements to obtain this certification:

1. Legal status and qualifications
The manufacturer must have a clear legal status, such as holding a legal person business license.
For manufacturing companies, a medical device production license or relevant filing certificate is required.

2. Quality management system
A quality management system that complies with ISO 13485 standards must be established, covering the entire process of product design, development, production, storage, sales, installation, maintenance and waste disposal.
The system must be in operation for at least 3 months and complete a complete internal audit and management review.

3. Risk management
Manufacturers must conduct risk management in accordance with ISO 14971, identify the risks that may exist in the life cycle of electric wheelchairs, and reduce these risks through design and control measures.

4. Technical documents and compliance
Prepare detailed technical documents, including product specifications, design drawings, circuit diagrams, component lists, clinical evaluation reports, risk management reports, etc.
Ensure that the product complies with relevant standards, such as EN 12184 (European standard for electric wheelchairs).
5. Production consistency
The manufacturer must ensure that each batch of electric wheelchairs produced meets the approved technical requirements and ensure the stability and consistency of product quality.
6. Post-marketing supervision
Establish a post-marketing supervision system to collect market feedback and ensure the safety and effectiveness of the product in actual use.
7. Other requirements
Electric wheelchairs must comply with relevant medical device directives, such as the EU MDR (Medical Device Regulation).
For products exported to the EU, they must also meet the relevant requirements of CE certification.
By meeting the above requirements, electric wheelchair manufacturers can ensure that their products meet international standards and improve product quality and market competitiveness.