IVD Instrument and Medical Device Custom Design & OEM
PreciGenome offers In Vitro Diagnostic (IVD) Instrument and medical device custom design and OEM solutions for customers who need prototyping and instrumentation. We have developed a wide range of OEM products for IVD applications in past years. With our design and manufacturing solutions, we can help you focus on your applications and your end customers to speed up your production development.
All our systems or components are available as OEM products. Our OEM products can easily be integrated into your complex instruments.
Are you looking for experts in medical designs with fluidic/pneumatic control?
Our goal is to work with our clients to develop their designs from concept to prototype and all the way on to production.
Our consulting practice includes developing and designing fluidic devices, instruments and processes with a focus on the early stages of product development. In past projects, we have designed, made and tested:
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Fluidic cartridges, microfluidic chips;
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Microfluidic chip manifolds;
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Liquid handling, fluidic control system;
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Pressure sources for ripple-free fluid pumping;
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Pneumatic, peristaltic and syringe-based instruments with embedded microprocessors for controlling flow through microfluidic systems;
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Thermoelectric heat exchangers, compact heat exchangers;
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Mechanical and control design for liquid dispensing robot;
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Software and firmware design.
Are you developing a medical system?
With our long experience in the field and our wide range of high-quality design, we can help you to find the best solutions for your system.
We provide a wide range of solutions, starting from high precision instruments and OEM components for complete and custom solutions.
• OEM high precision pressure/vacuum flow control system
• OEM fluidic cartridges by different materials
• OEM temperature controller
• Software and firmware design
• Customized tubing and fittings kit
• Manufacturing
Our OEM Solutions
System Solutions Cartridge Design Circuit Design Software
Process:
1. Project Definition
We offer thorough review of your existing concept to establish its feasibility and identify key modifications required to achieve a commercially viable, manufacturable product. We assess the requirements of the product based on our experience and capabilities. Together, we define the project and draw up an initial project plan.
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Design requirements
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Risks assessment
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Product breakdown
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Initial project plan
2. Feasibility and Concept
In this phase, we address technical risks using a rapid sprint based methodology where key risks are isolated and addressed with rapid design and build test work packages. We focus on feasibility and make an inventory of all the requirements and specifications for this project. Usually, we build proof-of-principle prototypes for laboratory testing
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Functional breakdown
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Proof of concept
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Cost estimation
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Risk analysis and management
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Time line management
3. Design Validation and Verification
Validation and verification testing to ensure that the detailed design specifications satisfy the design requirements. A serial of prototypes will be designed and built. We test and enhance until it meets the specifications and has all the required features. This process results in a verification report for the validated and locked-down product design which will now be ready for production.
We think ahead about scalable manufacturing processes to keep options open for future volumes. We start the build-up of our manufacturing process.
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Product design
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Prototyping and validation
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Iterations
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Product verification
4. Transfer from Design to Manufacturing
The design and manufacturing departments work together to safeguard the quality of the final product. They make sure all processes are set for transferring from design to manufacturing.
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Production planning
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Process validation
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Product validation
5. Manufacturing
Design, build, installation and wet commissioning of all pilot line infrastructure as per the manufacturing plan generated in earlier stages. Following the processes that ensure the quality of your product, we make sure we will produce the agreed-upon volumes and the products meet all the requirements.
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Quality Control
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Quality Assurance
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Production
Reasons to Choose us
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Design Expertise
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Cost-effective Solutions
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Logistics Proficiency for varied Quantities in Quick Time Periods
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Compliant with ISO 13485
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Experience in FDA/cFDA registration
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Small Business Agility
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World-Class Facility
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Flexible Shipping Options
Manufacturing Facilities
