Medical Component Manufacturing: Quality, Compliance, and Patient Safety
medical component
Manufacturing components for the Medical and Healthcare industries requires an unwavering commitment to quality, traceability, and regulatory compliance. At Polymach 360 , we operate as a highly controlled partner, specializing in the precision production of components and devices that meet the stringent requirements necessary for patient safety and clinical reliability.
We are dedicated to supporting innovators across diagnostics, surgical instruments, implantable devices, and drug delivery systems.
🔒 Quality and Regulatory Compliance
Our manufacturing framework is built upon robust Quality Management Systems (QMS) specifically designed for the MedTech sector. We don’t just meet standards; we make them the foundation of every process.
ISO 13485 Certified
This is the international gold standard for quality management systems in the medical device industry. Our certification demonstrates a commitment to regulatory requirements, risk management, and product realization tailored for medical devices.
Risk Management (ISO 14971)
We incorporate formal risk analysis into every stage of component design and manufacturing, proactively identifying and mitigating potential hazards.
Full Traceability
We maintain meticulous records for every component batch, including material certifications, process parameters, and inspection data, ensuring complete end-to-end auditability.
Clean Room Operations
Manufacturing for critical applications, where required, is performed in certified ISO Class [X] Clean Rooms to control particulate contamination, essential for components used in sterile environments or implantable devices.
🔬 Specialized Manufacturing Capabilities
We offer targeted manufacturing technologies optimized for the unique materials and demanding tolerances of medical components.
Precision Machining (CNC)
Critical for surgical tools, orthopedics, and complex housings.
- Tight Tolerance Milling & Turning: Achieving dimensional accuracies down to the micron level for mating components.
- Biocompatible Metals: Expertise in machining Titanium, 316L Stainless Steel, and Cobalt-Chrome alloys used in implants and instruments.
Medical-Grade Injection Molding
High-volume production of disposable and reusable plastic components.
- Biocompatible Polymers: Experience with high-performance, medical-grade materials such as PEEK, Ultem (PEI) (for sterilization resistance), Polycarbonate, and USP Class VI plastics.
- Micro-Molding: Production of extremely small, complex plastic parts for microfluidics and drug delivery devices.
Post-Processing and Assembly
We provide validated secondary operations to deliver finished, ready-to-use products.
- Finishing for Sterilization: Components are designed and finished to withstand methods like autoclaving, E-beam, or EtO sterilization.
- Medical Assembly: Including ultrasonic welding, bonding, and sub-assembly conducted under controlled environments.
- Surface Treatment: Including passivation (for stainless steel) and specialized coatings for wear resistance or enhanced biocompatibility.
🏥 Component Applications
Our manufactured components are used across a wide spectrum of healthcare devices, including
Surgical Instruments
Handles, housings, and precision internal mechanisms.
Diagnostic Equipment
Housings, fluidic manifolds, and sensor components.
Implantable Devices
Orthopedic screws, plates, and non-active components requiring high biocompatibility.
Drug Delivery
Disposable cartridges, pen injectors, and inhaler components.
