Conveying Systems
Machine Accessories
Special Purpose Machine
Product Range
Medical Device Manufacturing Facility
Transforming conceptual designs, existing parts or existing design into practical, high-quality solutions.
From inception to final manufacturing and
commercialization.
we can bring your ideas to life or create customise products & designs to fulfil your requirements.
Overview
We at KAIRISH Innotech pride ourselves on offering two key services to support your needs. First, we take the time to fully understand your requirements and then develop a fresh, tailored design and concept to meet your needs from inception to final manufacturing and commercialization. Whether you're developing a completely new product or enhancing an existing one, we can bring your ideas to life or create customise products & designs to fulfil your requirements. Alternatively, if you already have a commercialized product, we can assist you in scaling up production by upgrading your existing machinery or developing more advanced equipment to optimize the manufacturing process. Additionally, if you're looking to scale up the production of an existing device, simply provide us with your tech transfer, quality control protocols, and any other relevant details. We'll ensure that the same high standards are maintained throughout the production process.
We also offer the flexibility to assemble your existing designs and products in our state-ofthe-art facilities. If preferred, you can transfer your machines to our premises, where we will use our ready-to-use assembly areas to enhance your production capabilities. This seamless integration ensures that you benefit from both advanced infrastructure and expert support.
Our Custom or Pre Existing
Technologies For
Commercialization
Creating a New Design Concept to Final Manufacturing and Commercialization
Conceptualization and Design Planning
When a customer requests a completely new product, we start with Conceptualization and Design Planning, which serve as the foundation of the medical device development process. It begins with a comprehensive Needs Assessment, where we collaborate closely with healthcare professionals, stakeholders, and customers to thoroughly understand the specific requirements of the medical device. This includes defining its intended use, target market, and any customer-specific needs, ensuring the product will address real-world challenges effectively. Based on this information, we create a detailed Design Brief, which outlines the product’s functional specifications, performance criteria, and regulatory requirements.
The design brief serves as a roadmap for the entire design phase, guiding the team through the process of turning conceptual ideas into tangible, high-quality medical components that meet both customer expectations and industry standards. When working with a pre-existing design or product, we can either assemble, manufacture, or scale it as needed. This includes assembling machines, injection moulding, or simply receiving components and processing them in designated, classified areas.
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Pre-Production Modelling
Our engineers and designers work collaboratively to develop the initial concept of the medical device. This involves careful consideration of factors such as ergonomics, ease of use, material selection, and compatibility with existing medical systems to ensure that the product meets the practical needs of healthcare providers and patients.
Once the initial concept is defined, CAD Modelling is employed to create detailed 3D representations of the components using advanced Computer-Aided Design (CAD) software. These digital models provide a visual and functional prototype, allowing for preliminary testing of fit, function, and performance before physical production.
Material Evaluation
Material Selection and Testing is a critical step in the development of medical components, as the chosen materials directly impact the safety, performance, and longevity of the product. During Material Analysis, we carefully evaluate and select materials that are biocompatible, durable, and appropriate for the specific medical application—whether for drug delivery, injection, reconstitution, or other uses.
Materials such as medical-grade plastics, rubber, and metals are selected as per their proven performance, ability to withstand stress, and compliance with stringent medical standards.
Prototype Development
Next, prototyping is carried out using rapid prototyping, or the production of small-scale single-cavity moulds and tools. These techniques allow for early-stage testing and validation of the design's feasibility. This iterative process refines functionality, and ensure the product is ready for the next stage of development.
Commercial Production & Scape-Up
Once the product design and final prototype are approved, we have the capability to produce all necessary tooling and machinery—whether semi-automatic or fully automatic—entirely in-house. Our facilities are equipped with dedicated areas for machine installation, offering us great flexibility in customizing setups based on customer needs. We can begin with lowoutput machines for initial production runs and progressively scale up to high-output or mass-production systems as required.
We integrate stringent Quality Control procedures at every stage of the process to identify and rectify any deviations, ensuring that each product meets our high standards. Our cleanroom is certified according to ISO 14644 standards, ensuring a controlled environment that meets the highest levels of cleanliness and safety. This controlled environment minimizes the risk of contamination, especially for devices that will come into direct contact with patients or drug products. We can also operate our machines under Laminar Air Flow (LAF) system.
Regulatory Conformance &
Site Approvals
Regulatory Compliance and Validation are central to our medical device manufacturing process, ensuring that all medical devices meet the highest standards of safety, efficacy, and quality
To comply with regulatory requirements, we prepare and maintain detailed documentation for each product. This includes-Design History Files (DHFs), Device Master Records (DMRs), Risk Management Files.
To comply with regulatory requirements, we prepare and maintain detailed documentation for each product. This includes-Design History Files (DHFs), Device Master Records (DMRs), Risk Management Files.
These documents provide a clear traceability record, demonstrating that each product has undergone rigorous testing and validation to meet regulatory requirements. They also ensure that the devices we produce are safe for their intended use and perform as expected. Certified by ISO 9001:2015 and ISO 13485:2016, which govern quality management and risk management practices throughout the design and manufacturing phases. These certifications confirm our commitment to consistent product quality and operational excellence.
In addition to ISO standards, we are also audited & approved by CDSCO (Central Drugs Standard Control Organisation) for the sterile medical devices that we produce currently. We prepare comprehensive documentation to demonstrate that each product meets the stringent safety, performance, and regulatory requirements. Our Design Validation and Verification processes are critical to ensuring that the product meets its intended use and safety requirements.
These documents provide a clear traceability record, demonstrating that each product has undergone rigorous testing and validation to meet regulatory requirements. They also ensure that the devices we produce are safe for their intended use and perform as expected.
Certified by ISO 9001:2015 and ISO 13485:2016, which govern quality management and risk management practices throughout the design and manufacturing phases. These certifications confirm our commitment to consistent product quality and operational excellence.
In addition to ISO standards, we are also audited & approved by CDSCO (Central Drugs Standard Control Organisation) for the sterile medical devices that we produce currently. We prepare comprehensive documentation to demonstrate that each product meets the stringent safety, performance, and regulatory requirements.
Our Design Validation and Verification processes are critical to ensuring that the product meets its intended use and safety requirements.
Material Selection Expertise
As a custom parts and components manufacturer, the ability to select and work with a variety of materials—metals, plastics, composites, and alloys—is our forte. We understand the properties of materials (strength, hardness, heat resistance, corrosion resistance etc.) which is essential for choosing the right material for each application.
As a custom parts and components manufacturer, the ability to select and work with a variety of materials—metals, plastics, composites, and alloys—is our forte. We understand the properties of materials (strength, hardness, heat resistance, corrosion resistance etc.) which is essential for choosing the right material for each application.
Flexible Production Capacity
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Flexible Production Capacity
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1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.
Flexible Production Capacity
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Flexible Production Capacity
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the
1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.
Flexible Production Capacity
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Manufacturing Process
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CNC MACHINING
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TURNING AND MILLING
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GRINDING
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INJECTION MOULD
MANUFACTURING
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Customisation & Flexibility
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Customisation & Flexibility
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Customisation & Flexibility
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Customisation & Flexibility
Quality Control &
Final Inspection
Quality Control and Final Inspection are integral parts of our manufacturing process, ensuring that every product meets the highest standards of safety and performance. In the final stage of production, each product undergoes a rigorous Inspection and Testing process, which includes detailed visual inspections, dimensional checks, and functionality tests. These procedures are designed to confirm that every component adheres to the required specifications and complies with regulatory standards.
Scaling Up Production for an Existing Commercialized Product
Tech Transfer
If our customers already have an existing design and a smaller manufacturing setup, or if they wish to transfer their operations to an external facility, we have already set up dedicated spaces to facilitate this transition smoothly. Additionally, we can set up larger machines as an
alternative site to complement or scale up their current production, ensuring a smooth and efficient transfer of operations.
It begins with receiving detailed design documentation, including technical drawings, specifications, material lists, and quality control (QC) guidelines. This information serves as the foundation for replicating the product with high accuracy. Next, we review the client’s existing manufacturing processes, carefully analyzing each step to identify potential areas
for improvement and ensure alignment with the latest industry best practices. Finally, we assess the client’s current QC protocols, ensuring they are robust and well-implemented for the scaled-up production. This thorough evaluation guarantees that product quality remains
consistent, and any necessary adjustments are made to accommodate higher volumes while maintaining compliance with regulatory standards.
Regulatory Conformance &
Site Approvals
Regulatory Compliance and Validation are central to our medical device manufacturing process, ensuring that all medical devices meet the highest standards of safety, efficacy, and quality
To comply with regulatory requirements, we prepare and maintain detailed documentation for each product. This includes-Design History Files (DHFs), Device Master Records (DMRs), Risk Management Files.
These documents provide a clear traceability record, demonstrating that each product has undergone rigorous testing and validation to meet regulatory requirements. They also ensure that the devices we produce are safe for their intended use and perform as expected.
Certified by ISO 9001:2015 and ISO 13485:2016, which govern quality management and risk management practices throughout the design and manufacturing phases. These certifications confirm our commitment to consistent product quality and operational excellence.
In addition to ISO standards, we are also audited & approved by CDSCO (Central Drugs Standard Control Organisation) for the sterile medical devices that we produce currently. We prepare comprehensive documentation to demonstrate that each product meets the stringent safety, performance, and regulatory requirements.
Our Design Validation and Verification processes are critical to ensuring that the product meets its intended use and safety requirements.
Quality Control &
Final Inspection
Quality Control and Final Inspection are integral parts of our manufacturing process, ensuring that every product meets the highest standards of safety and performance. In the final stage of production, each product undergoes a rigorous Inspection and Testing process, which includes detailed visual inspections, dimensional checks, and functionality tests. These procedures are designed to confirm that every component adheres to the required specifications and complies with regulatory standards.
Supply Chain &
Inventory Management
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Operational Scale of our
Medical Device Facility
Our medical device manufacturing facility is split into various areas which collectively spans an impressive 26,000 square feet, providing a premier environment for the design, development, and production of high-quality medical devices. This expansive space spans two dedicated floors, each equipped with ISO 14644 certified cleanrooms, fully prepared to accommodate equipment and start production swiftly.
Additionally, we have a separate, specialized area for in-house ETO sterilization, ensuring streamlined and efficient manufacturing capabilities. The large scale of our facility enables us to accommodate highvolume production while maintaining strict adherence to industry standards and regulatory requirements.
“ We received a unique request from one of our customers, who presented us with a product
concept they wanted to develop, from there, we did it all—from sourcing materials in the USand refining the design, to creating injection moulds and manufacturing components in- house. We even built the assembly machine ourselves, handled sterilization, and packed the products. But we didn’t stop there! We went the extra mile by designing and building a fully customized
final packing line where our product is combined & packed with the customer’s product. And,
in the end, we continued to deliver millions of pieces! Talk about going the extra mile! ”
Knowledge
Nuggets
“ Did you know we offer sterile medical devices with the highest safety standards? We’ve got
you covered with flexible sterilization options—whether it's in-house ETO, steam sterilization,
or external Gamma sterilization—whatever suits the part or your preferences best! ”