ISO 13485:2016 certified & GMP complaint
Class 1000 (ISO Class 7) cleanroom
In-house mold tooling workshop
Medical-grade materials validated per ISO 10993
Experience in overmolding and insert molding
DFM analysis to eliminate tooling risk before production
Why Choose Fecision
DFM review before mold tooling
IQ/OQ/PQ validation timeline on schedule
Raw materials logged & Finished-part records
FDA 21 CFR Part 820 & ISO 13485 traceability
Injection molded sterile-path components
Particle counts monitored per ISO 14644-1
Every medical program follows a validated, documented sequence. No shortcuts. No ambiguous handoffs.
Submit your part drawing, material & technical spec, and annual volume. We return a detailed quotation — including mold cost, unit price, and lead time — within 2 business days.
Our engineers review gate placement, wall thickness, parting line, and draft angles. A written DFM report is issued before mold design begins — eliminating avoidable tooling revisions.
Precision mold design and manufacturing to 0.002 mm machining accuracy. Material: S136 / SKD61 cavity steel. Surface finish: Ra ≤ 0.2 μm. Full dimensional report issued on mold completion.
First-article T1 trial in production conditions — same press, same cleanroom class, same material lot as production. Dimensional results measured by 3D optical CMM to ±0.003 mm resolution.
Pre-production sample sets provided for IQ/OQ/PQ validation activities. Dimensional reports, material certificates, and process parameters documented to support regulatory submission.
ISO 13485-controlled production with in-line inspection, batch traceability, and on-time delivery. Monthly capacity available for medical projects from 5,000 to 200M+ parts.
Fecision collaborates with clients to develop and manufacture a wide range of components for advanced drug delivery systems, including syringes, infusion ports, Luer connectors, and aerosol valves, serving medical applications that demand rigorous tolerance standards for assembly.
Fecision manufactures pharmaceutical and laboratory consumables including packaging, auxiliary and sampling tools, tailored to the needs of the pharmaceutical, medical diagnostics, and biological research sectors.
We maintain rigorous standards regarding both material purity and sealing integrity to serve a wide range of applications.
Respiratory and anesthesia devices demand hermetic seals, soft-touch patient contact surfaces, and zero particulate contamination.
Fecision combines LSR (liquid silicone rubber) two-shot molding with thermoplastic injection in Class 1000 cleanrooms to produce masks, valves, and tubing connectors that perform under pressure.
In the fields of medical aesthetics and healthcare, Fecision has participated in key projects for high-end medical aesthetics brands, successfully helping to launch numerous best-selling products.
Our solutions are widely applied across a diverse range of devices, including beauty instruments, therapeutic devices, diagnostic equipment, hydro-injection systems, and microneedle rollers.
ISO 13485-certified medical plastic injection molding with validated processes and full material traceability. We deliver tight-tolerance components for Class I–III devices from Class 7 cleanrooms, ensuring consistent quality and regulatory compliance from prototype to production.
Who We Are
Since 2010, Fecision has been manufacturing injection molded parts and long served world-renowned companies in the fields of medical care. We have advanced solid and liquid production and testing equipment, with our own independent mold workshop. Our annual production capacity exceeds hundreds of millions of pieces.
Fecision obtains a number of product invention patents and utility model patents, and has won the honor of high-tech enterprises. Our existing products are sold to the United States, Japan, Midwest, Southeast Asia and other countries or regions, and have established good partnerships with customers.
Project Manager
Yaowei Chen
Engineering Manager
Yongjin Zhu
Quality Manager
Jinrong Yin
PMC Supervisor
Liwen Zhu
Equipped with our own mold tooling workshop, we complete mold design, manufacturing and maintenance in-house.
All raw materials are traceable throughout every production procedure.
Class 1000 (ISO 7) and Class 10,000 (ISO 8) cleanroom environments with continuous particle count monitoring and documented batch records.
Our on-site QC laboratory conducts strict inspections throughout production..
Our commitment to precision manufacturing is validated by international standards across medical device and silicone molding sectors.
Quality Management System
Medical Devices QMS
Environmental Management
Occupational Health & Safety
Hazardous Substances Control
Good Manufacturing Practice
ZD Testing
ZD Testing
1. Class 1000 / Class 10,000 Cleanroom Environment
2. Surface glossiness can reach Grade A1
3. Medical-grade liquid and solid silicone raw materials and color pastes
4. Capable of accommodating complex, irregular shapes and features with partial undercuts.
1. Medical-grade polymers selected for skin-contact safety and sterilization compatibility
2. Totally automatic production process
3. Tight dimensional tolerances: mass-production (0.25mm, 0.5mm) and small-batch (1.0mm–2.0mm) needle variants through precision-molded interface geometry
4. Class I Medical Device Certification (for medical microneedle rollers) and Class II Medical Device Certification (for cosmetic microneedle rollers).
Redesign the cushion seal for anesthesia mask production— transitioning from compression-molded HTV silicone to
liquid silicone rubber (LSR) injection molding to eliminate manual trimming, improve seal consistency
1. Pressure-test pass rate: 99.7% (vs. industry benchmark 96%)
2. Patient comfort improvement: attributed to uniform 1.2mm cushion wall and softer shore durometer
Your Questions | Our Solutions
Questions from engineering managers, QA directors, and procurement teams evaluating medical molding partners. Answered with actual process data.
Yes. DFM is a mandatory gate in our medical project workflow — not an optional add-on.
Class 1000 (ISO 7) cleanroom for all medical-grade production.
DFM review avaliable
ISO 13485: 2016 certified - GMP compliant
Class 1000 (ISO 7) cleanroom - operational state certified
Full IQ/OQ/PQ validation package delivered
Lot traceability-resin COA to finished part DHR
PEEK . LSR . PPSU - PP . ABS all supported
Million+ medical parts per month-proven production scale
In-house tooling-- ±0.003 mm cavity precision
You can also upload your files to sales01@fecision.com directly.
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Get in Touch
Email: sales01@fecision.com
