ISO 13485 Medical Silicone Manufacturer
Custom LSR injection molding and medical silicone component manufacturing, supported by ISO 13485 quality management, ISO Class 8 cleanroom production, and in-house engineering and tooling.
About LSR INJECTION
LSR Injection is an ISO 13485-certified medical silicone manufacturer specializing in custom LSR injection molding and precision components.
With an ISO Class 8 cleanroom, in-house tooling and engineering, we support Class I & II medical device projects from prototyping to production.
OUR PRODUCTS
Medical Silicone Components & Applications
Explore our medical and specialty silicone product categories, including custom molded components, CPAP parts and medical tubing. OEM/ODM support from tooling to production.
MEDICAL SILICONE DEVELOPMENT
From Design to Production
We work with medical device teams on design review, material selection, custom tooling and production. Our engineers consider manufacturability and project requirements from the start.
Engineering & DFM
Review geometry, material options and manufacturing feasibility.
Mold Development
Develop precision tooling around critical component features.
Prototype Evaluation
Evaluate samples against agreed functional requirements.
Controlled Manufacturing
Transition to repeat production with defined inspection criteria.
WHY LSR INJECTION
Manufacturing Capabilities Built for Medical Projects
Our focus is on practical engineering support, consistent production and the quality controls medical device teams expect from a manufacturing partner.
ISO 13485 Quality System
Documented quality management practices to support controlled manufacturing and customer requirements.
ISO Class 8 Cleanroom
A controlled environment available for medical silicone projects that require cleanroom production.
In-house Precision Tooling
Tooling design and manufacturing support for complex features, fit and surface requirements.
LSR & Silicone Molding
Injection molding, compression molding and extrusion options selected for the component design.
Engineering Collaboration
DFM input, material selection and prototype reviews before the production tool is finalized.
Inspection & Traceability
Inspection criteria and production records aligned with the approved project scope.
CUSTOM MANUFACTURING
More Than Silicone Molding
We coordinate the steps that turn a medical silicone component design into a repeatable, production-ready part.
Engineering Review
CAD review, DFM input and early material and process evaluation.
Custom Tooling
Mold development and design adjustments to meet agreed requirements.
Secondary Operations
Post-curing, trimming, assembly, marking and packaging as specified.
Production Support
Sampling, repeat production and inspection with clear project communication.
Available processes and documents depend on the component, agreed manufacturing scope and intended medical application.
PROCESS SELECTION
Choose the Right Silicone Manufacturing Process
Part design, material grade, volume and functional requirements determine which molding method fits the project.
Medical LSR Injection Molding
For intricate geometries and repeat production of precision silicone components.
- Integrated sealing details
- Valves and flexible components
- Scalable, repeatable molding
Silicone Compression Molding
A useful option for selected HCR materials, geometries and production requirements.
- Custom seals and membranes
- Material and hardness options
- Application-specific designs
Medical Silicone Extrusion
For continuous tubing and profiles requiring defined dimensions and material properties.
- Medical silicone tubing
- Continuous cross-sections
- Custom profile requirements
Have a Medical Silicone Component in Development?
Send us a drawing or a brief description of your project. We can discuss material, tooling and manufacturing options.
QUALITY & PRODUCTION CONTROL
Medical Silicone Quality Assurance
ISO 13485 quality management, ISO Class 8 cleanroom capability and defined inspection processes support our medical silicone manufacturing projects.
CONTROLLED MANUFACTURING
ISO Class 8 Cleanroom Production
Our ISO Class 8 cleanroom provides a controlled environment for medical silicone parts requiring defined cleanliness conditions. Production procedures and inspection criteria are reviewed according to each project’s needs.
Quality documentation and project-specific testing requirements are confirmed during supplier qualification.
ISO 13485 Quality Management
Documented procedures support controlled production and quality oversight.
In-Process Inspection
Defined dimensional, visual and functional checks support consistency.
Material & Batch Traceability
Relevant material identification and production records are managed by project scope.
DESIGN CONSIDERATIONS
Developing Reliable Medical Silicone Components
Medical silicone part performance starts with product requirements and thoughtful decisions made before tooling.
Material & Hardness
Select LSR or HCR formulations against contact conditions, hardness, mechanical performance and documentation needs.
Geometry & Tolerances
Review wall thickness, critical fit features, parting lines and achievable tolerances during DFM.
Flash & Surface Finish
Plan tooling details, visual expectations and inspection criteria before the component enters repeat production.
OUR FACILITY
Manufacturing Facility & Quality Documentation
A closer look at our tooling, silicone molding equipment and quality-focused manufacturing environment.
IN-HOUSE MANUFACTURING
Tooling, Molding & Inspection
LSR Injection combines precision mold-making with LSR injection molding and complementary silicone processes. Engineering, production and quality teams coordinate around project requirements.
- LSR molding and silicone processing
- Precision mold manufacturing
- Dimensional and appearance inspection
QUALITY & COMPLIANCE
Quality Certifications & Documentation
Our quality framework includes ISO 13485 and ISO 9001 quality management systems, supported by an ISO Class 8 cleanroom and documented manufacturing controls.
We also maintain FDA registration documentation and a SMETA audit report. Applicable certification scopes, testing and project-specific records are reviewed according to customer requirements.
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START A PROJECT
Discuss Your Medical Silicone Project
Share your application, drawings or specifications and expected production volume. Our team will review your requirements.