Medical Device Manufacturing Services
Frigate delivers high-precision medical device components using advanced casting and machining techniques. We apply strict dimensional tolerances and rigorous testing to ensure device integrity and compliance.Â
Our Clients
Advantages of Medical Device Manufacturing Services
Precision Manufacturing
Medical devices require tight tolerances, ensuring optimal fit and function. Advanced machining techniques guarantee high accuracy in every component.
Material Integrity
We use biocompatible and durable materials to ensure that medical devices meet safety standards and withstand the demands of healthcare environments.
Regulatory Compliance
Our processes adhere to rigorous industry standards, ensuring that all medical devices are FDA-approved and compliant with medical regulations.
Quality Control
Continuous quality assurance measures, including non-destructive testing, ensure that all manufactured devices meet performance, safety, and durability requirements.
Custom Medical Device Manufacturing - Precision and Compliance at Every Step
Custom medical device manufacturing ensures components are designed and produced to meet specifications. Advanced materials and precision machining techniques achieve tight tolerances, ensuring optimal performance. Biocompatible alloys and strict quality control measures are applied to meet regulatory standards, including FDA compliance. Every step in the process focuses on delivering high-quality, reliable components that support the functionality and safety of medical devices in demanding environments. This approach ensures consistent results for critical applications, from design through production to testing.Â
Get Your Quote Now
- Instant Quotation
- On-Time Delivery
- Affordable Cost
Our Medical Device Manufacturing Process
Initial designs are created based on functional requirements. Prototypes are developed and tested for design feasibility and performance.Â
Biocompatible materials are chosen for their durability, safety, and ability to meet medical standards. These materials are carefully sourced and tested for compatibility.Â
Components are manufactured using advanced machining techniques. Tight tolerances are maintained to ensure that each part meets strict specifications for fit and function.Â
Individual components are assembled into finished medical devices. Automated and manual processes ensure precision and proper integration of parts.Â
Rigorous testing is performed to validate device functionality, safety, and compliance with industry standards. This includes mechanical, electrical, and biocompatibility tests.Â
The final device undergoes regulatory review to ensure compliance with standards like FDA approval. Documentation and certification are provided for medical device safety and performance.
Industries We Serve
Initial designs are created based on functional requirements. Prototypes are developed and tested for design feasibility and performance.Â
Biocompatible materials are chosen for their durability, safety, and ability to meet medical standards. These materials are carefully sourced and tested for compatibility.Â
Components are manufactured using advanced machining techniques. Tight tolerances are maintained to ensure that each part meets strict specifications for fit and function.Â
Individual components are assembled into finished medical devices. Automated and manual processes ensure precision and proper integration of parts.Â
Rigorous testing is performed to validate device functionality, safety, and compliance with industry standards. This includes mechanical, electrical, and biocompatibility tests.Â
The final device undergoes regulatory review to ensure compliance with standards like FDA approval. Documentation and certification are provided for medical device safety and performance.
Our Medical Device Manufacturing Process
Achieving Regulatory Compliance with Full Traceability and Post-Manufacturing Support
Frigate provides comprehensive post-manufacturing support by maintaining clear, detailed records for each device produced. Traceability is ensured through advanced tracking systems, documenting each component’s lifecycle from design through production and testing. This thorough documentation guarantees compliance with regulatory requirements and supports long-term device monitoring. Frigate’s traceability systems allow for easy information retrieval, ensuring full transparency and product integrity. These processes help customers meet stringent industry regulations while ensuring ongoing support throughout the device’s lifecycle.Â
Medical Device Manufacturing Materials
At Frigate, advanced machining and testing ensure precise, reliable medical device components. Strict quality control and regulatory compliance guarantee safety, functionality, and durability.Â
Stainless Steel (316L) offers exceptional corrosion resistance and mechanical strength. It is ideal for surgical tools, implants, and devices requiring high sterilization durability with minimal risk of material degradation.Â
Provides superior strength-to-weight ratio and corrosion resistance, especially in joint replacements and dental implants. Its non-reactive nature makes it highly biocompatible, preventing adverse reactions in the body.Â
Known for high wear resistance and fatigue strength. These alloys are used in load-bearing implants like hip replacements, providing long-term durability and minimal wear under mechanical stress.Â
A high-performance polymer used in spinal implants and orthopedic devices. It offers exceptional mechanical properties, chemical resistance, and biocompatibility, making it suitable for load-bearing applications.Â
This highly flexible and biocompatible material is used in soft tissue implants, gaskets, and seals. Its resistance to temperature extremes and sterilization techniques make it ideal for long-term medical use.
A high-strength ceramic used in dental and orthopedic implants. Known for its wear resistance, biocompatibility, and aesthetic qualities, it provides an effective alternative to metals in high-stress applications.Â
Highly chemically resistant and non-reactive, used in coatings for surgical instruments, implants, and catheters. PTFE's low friction properties ensure smooth operation and reduce the risk of irritation.Â
Borosilicate Glass offers high resistance to thermal shock, chemical corrosion, and mechanical stress. It is commonly used in diagnostic equipment and pharmaceutical vials, where clarity and chemical stability are essential.Â
Optimizing Medical Device Components for the Biopharmaceutical Industry
The need for consistent, high-quality medical device components in biopharmaceutical manufacturing is paramount. Variability in production processes can lead to compliance risks and functionality concerns. Frigate addresses these challenges, focusing on advanced manufacturing techniques, including multi-axis CNC machining and material traceability. These methods ensure that components are precisely engineered to meet the unique demands of biopharmaceutical devices, offering high-quality solutions that adhere to stringent regulations, improve device reliability, and expedite time-to-market.Â
- Solid Progress
What You Gain with Us
We make your profitability and operations easier with practical approach.
↓ 7-8%
OPS COST
↓ 2-3%
COGM
3X
Aggregation
↑ 25%
Machinery Utilisation
↓ 50%
Expedition
↑ 30%
Frigater Revenue
Uninterrupted Production with Reliable Supply Chain Management
Frigate ensures supply chain reliability by utilizing advanced inventory management systems and forming strategic partnerships with trusted suppliers. By implementing real-time tracking and forecasting, Frigate minimizes material shortages and delays. The company uses a robust logistics strategy, ensuring timely delivery of critical materials to maintain production schedules. With consistent supplier communication and proactive inventory management, Frigate ensures a steady flow of high-quality materials, preventing disruptions and ensuring continuous production of medical devices without compromising deadlines.Â
Check Out Our Blogs
What Our Customers Say about Frigate
21%
Faster Manufacturing
Having Doubts? Our FAQ
Check all our Frequently Asked Question
Frigate utilizes advanced CNC machining and laser measurement systems to maintain tight tolerances. This ensures that each component meets stringent specifications for optimal fit and function.Â
Frigate carefully selects biocompatible materials and performs comprehensive testing, including cytotoxicity and sensitization assays, to confirm compliance with industry standards like ISO 10993.Â
Frigate employs multi-axis CNC machining, 3D printing, and precision casting to fabricate complex geometries with high accuracy, ensuring functionality without compromising strength or performance.Â
Frigate implements automated and manual inspection processes, including non-destructive testing (NDT), to detect and eliminate defects before products move to the next stage.Â
Frigate follows strict FDA guidelines, implementing risk management practices, documentation control, and traceability to guarantee that all devices meet regulatory requirements for safety and performance.Â
We'd love to Manufacture for you!
Submit the form below and our representative will be in touch shortly.
LOCATIONS
Global Sales Office
818, Preakness lane, Coppell, Texas, USA – 75019
Registered Office
23, 6th West Street, Balaji Nagar, Kattur, Pappakuruchi, Tiruchirappalli-620019, Tamil Nadu, India.
Operations Office
9/1, Poonthottam Nagar, Ramanandha Nagar, Saravanampatti, Coimbatore-641035, Tamil Nadu, India. ã…¤
