Medical & Aesthetic Device Injection Molding
Medical and device-component molding reviewed against the specific quality-system scope, material, contamination, validation, traceability, packaging, and regulatory requirements of the program.
- Process
- Medical and device-component injection molding
- Engineering path
- Drawing review → DFM → tooling → trials → production
- Press range
- 80–850 tonnes; final press selection depends on the part and tool
- Location
- Tainan, Taiwan
- Company
- LongTeam Industrial Co., Ltd., founded in 1989
- Quality system
- ISO 13485 wording retained; verify current certificate and program scope
Define the device requirement before the process
Part function, patient or user contact, material, cleanliness, dimensions, appearance, tests, packaging, traceability, and regulatory pathway determine the supplier and process evidence required.
Verify quality-system scope
Review the current ISO 13485 certificate, legal entity, site, activities, exclusions, issuing body, and expiry. Certification does not by itself establish a cleanroom class or approve a specific part.
- Confirm certificate scope
- Define program records
- Agree on change notification
Control material and contamination risk
Approve the exact grade and supporting evidence, then define handling, cleaning, environment, regrind, storage, packaging, and traceability from the device risk.
Plan validation and release evidence
Agree on tool and process validation, measurement, functional testing, deviations, retained records, and production release responsibilities.
The same engineering path, adapted to your program.
See how analysis, tooling, and process learning stay connected from review through production. Findings and acceptance criteria are defined for each program.
Review geometry, material, gates, ejection, and tooling risks before steel is cut.
LongTeam injection mold tooling, built to carry engineering decisions into production.
Use dimensional and process data to identify variation and guide engineering decisions.
Medical Injection Molding Supplier Qualification: ISO 13485, Materials, and Process Evidence
First Article Inspection (FAI) for Injection Molded Parts: OEM Buyer's Complete Guide
Plastic Injection Molding Material Selection Guide: ABS, PC, Nylon, PP, PEEK and How to Choose
Frequently asked questions
Related capabilities and program guidance
Prepare the right information for an engineering review.
Share the drawing, material, expected volume, and critical requirements so LongTeam can clarify the project and quotation scope.