Medical Molding Solutions.
ISO 13485 Compliant Network.
From high-cavity pipette tips to complex surgical device housings. We deliver precision molds and parts within certified Clean Room environments.
Quality is Non-Negotiable
Manufacturing Standards You Can Trust
We understand that in medical, quality is non-negotiable. Our manufacturing partners are strictly audited to ensure compliance and reliability.
ISO 13485:2016
Comprehensive management system for medical device design and manufacturing.
Clean Room Class 7 & 8
(10k & 100k) environments for low-particulate molding and assembly.
FDA / USP Class VI
Ensuring material compliance and bio-compatibility for all components.
Expertise Across Medical Sectors
We provide specialized molding solutions tailored to the unique requirements of different medical applications.
Laboratory Consumables
Focus
High Cavity (32-128 cavities), Fast Cycle, High Transparency.
Parts
Pipette tips, Petri dishes, Test tubes, PCR plates.
Medical Device Housings
Focus
Aesthetic finish, Durability, EMC Shielding (Insert molding).
Parts
MRI casings, Handheld monitors, Ventilator enclosures.
Surgical & Drug Delivery
Focus
Micro-tolerance, Multi-component (2K).
Parts
Syringe components, Inhalers, Surgical handles (Soft touch).
Validation & Documentation Support
We don't just ship parts; we provide the comprehensive paperwork required for your FDA/CE submission, ensuring a smooth regulatory path.
-
IQ (Installation Qualification)
Verifying equipment installation against manufacturer's specifications.
-
OQ (Operational Qualification)
Testing process windows to establish High/Low limits for critical parameters.
-
PQ (Performance Qualification)
Conducting stability runs (e.g., 24-hour continuous run) to prove process capability.
-
Traceability
Full lot tracking system from resin batch to final shipping carton.
Streamlined Regulatory Path
We handle the documentation burden.
Bio-Compatible Materials
Extensive experience with medical-grade resins requiring strict handling, storage, and processing parameters to maintain compliance.
Rapid Scale-up for a Diagnostic Kit Manufacturer
The Challenge
Client needed 500k parts/week for a new test kit amidst surging demand. Their existing mold cycle time was too slow to meet production targets.
The Solution
Vanshol engineered a high-performance 64-cavity stack mold incorporating advanced conformal cooling technology to optimize heat dissipation.
The Result
Cycle time was reduced by 40%. We delivered high-quality T1 samples in just 45 days, enabling the client to capture market share rapidly.
Requires strict confidentiality and compliance?
Partner with a manufacturer that understands the sensitivity of medical development. We protect your IP and ensure full regulatory adherence.