ISO 13485 Quality Management Supports Medical Silicone Manufacturing Projects
sourceSiliconePlus Compliance Team
publishersiliconeplus
time2026/08/08
- ISO 13485:2016 quality management supports controlled production, documentation and quality processes for customized medical silicone manufacturing projects.
Medical silicone manufacturing requires stricter control of materials, production processes, documentation and product quality than many conventional molded-part projects.
The manufacturing entity supporting SiliconePlus is certified to ISO 13485:2016 within the scope stated in the applicable certification documentation.
The quality management system provides a structured framework for manufacturing medical silicone products while supporting controlled production and documented quality processes.
Why ISO 13485 Matters for Medical Silicone Projects
For custom medical silicone components, stable production requires more than selecting a suitable silicone material.
Manufacturing control may involve material management, tooling, process parameters, dimensional inspection, product traceability and documented quality records.
An ISO 13485 quality management framework can support areas such as:
- material and supplier control;
- documented manufacturing processes;
- inspection and quality records;
- traceability;
- nonconforming product management;
- corrective and preventive actions;
- continuous process improvement.
Medical Silicone Manufacturing Capabilities
SiliconePlus supports customized medical silicone projects involving applications such as medical seals, silicone valves, plugs, protective components, sensor interfaces and selected LSR overmolded structures.
Manufacturing support can include:
DFM review, material evaluation, precision tooling, LSR injection molding, silicone overmolding, sampling, dimensional inspection and OEM mass production.
Customers can provide drawings, samples, application requirements and expected quantities for engineering evaluation.
Certification Status
Standard: ISO 13485:2016
The certification document currently available for this manufacturing entity shows:
First Certification: August 10, 2023
Certificate Expiry Date: August 9, 2026
Certification status should always be confirmed using the latest valid documentation.
When renewed certification documentation becomes available, the latest certificate information should replace the current version.
Customers requiring medical project qualification documents can request the latest applicable certification information during supplier or project review.