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At iDES, a leading medical device design and development company, we use a special Maniac-Elegant approach to create devices that have a strong emotional bond between users and systems.
We provide solutions, including MVP prototyping, contract manufacturing, and integration services. With over 15 years of team experience, we have delivered successful devices like laboratory & therapeutic equipment, home medical equipment, durable medical equipment (DME), monitoring equipment and ICU multiparameter monitor. Our expert team combines industrial and electronic design with human-centered research, ensuring designs are ergonomically optimized and FDA compliant. In addition, we focus on building UI/UX to work better along with software development.
We focus on practical, user-friendly designs that meet ISO 13485 and regulatory standards, guaranteeing high-quality products from concept to manufacturing, making us a trusted partner in the field.
We ensure your product complies with industry standards like CDSCO, FDA, ISO 13485, and CE, minimizing risks and ensuring safety and effectiveness.
Our expert team ensures a smooth product development process, accelerating your medical device's time-to-market and enabling you to deliver innovative healthcare solutions efficiently and effectively.
We focus on human-centered design, ensuring our devices are intuitive and easy to use, ultimately improving patient outcomes and promoting greater adoption in the healthcare industry.
By optimizing the design for manufacturing, we reduce material waste and improve production efficiency, lowering your overall product costs without sacrificing quality and consistency.
Through our prototyping and testing services, we help identify design flaws early, ensuring your device is functional, usable, and meets regulatory and biocompatibility standards before mass production.
Our expertise in advanced electronic design allows us to create medical devices with precision, functionality, and connectivity, providing smarter solutions for healthcare professionals.
We create designs that are highly reliable, user-friendly medical equipment, including Laboratory, Therapeutic, Home Medical, Durable Medical Equipment (DME), Monitoring Equipment, and other sophisticated devices made for medical/healthcare professionals.
Using our Maniac-Elegant approach, we create medical devices that facilitate emotional bonds between users, doctors, and patients, elevating user experience and satisfaction for better care.
With extensive experience, our team utilizes CAD-based tools to identify and solve complex problems early, ensuring smooth compliance and certification for safe, reliable medical devices.
We prioritize IP protection, securing designs, and ensuring customized solutions for the healthcare sector while maintaining high standards of quality and safety in all developments.
The first phase involves assessing the market, competition, and regulatory requirements, ensuring a clear understanding of legal and financial agendas.
Design inputs are collected while considering risk assessment and potential challenges. This stage builds a strong foundation for the project, focusing on compliance, strategic analysis, and financial feasibility to support the next steps of development. Detailed planning at this stage minimizes potential issues down the line.
Also, we plan an IP strategy before we actually begin with the product development.
During this phase, the concept of the device is created, incorporating initial design input. Prototypes are developed and evaluated to determine feasibility and performance in real-world scenarios. Pre-clinical trials and evaluation refine the design further.
This phase involves creating a tangible version of the idea and assessing its practicality. Iterative prototyping enables efficient testing and validation of the concept.
This phase integrates key design input to create a comprehensive set of design specifications, leading to the development of the product.
Through detailed design output, the product’s feasibility and performance are verified. Design failure modes are considered, and risk management is actively incorporated. Design validation tests and the Device History File (DHF) are documented thoroughly.
With design specifications and outputs finalized, the device enters manufacturing, either in pilot runs or full-scale production. Design validation ensures that the product performs as intended in the real world as well.
A comprehensive process validation includes testing, quality assurance, and compliance checks. Clinical research projects may be conducted to ensure safety and efficacy in real-world applications. This stage brings the device closer to market.
Once the product is launched, ongoing training, audits, and updates are essential to ensure continued compliance and optimal performance.
Post-market surveillance gathers data from actual users, helping refine future iterations. This phase ensures that potential issues are addressed promptly while monitoring long-term device performance. Customer feedback plays a pivotal role, enabling proactive adjustments to the design, manufacturing, and overall user experience to maintain the device’s effectiveness.
Medical device design and development is a highly regulated, multidisciplinary process of conceptualizing, designing, prototyping, testing, and validating devices intended for medical purposes. It encompasses everything from initial ideation and feasibility studies to regulatory submission, manufacturing specifications, and post-market surveillance, ensuring the device is safe, effective, and compliant with global health authority standards.
We specialize in designing a broad range of medical devices, with particular expertise in areas such as:
Laboratory & therapeutic equipment
Home medical equipment
Durable medical equipment (DME)
Monitoring equipments
ICU multiparameter monitor
Our focus is on devices that prioritize user-centric design, clinical efficacy, and regulatory compliance across their lifecycle.
Yes, we provide comprehensive support that extends beyond just design to include the critical manufacturing process for medical devices. Our services encompass design for manufacturability (DFM) considerations during the initial stages, selecting appropriate manufacturing partners, overseeing production, and establishing quality control protocols. This integrated approach ensures a smooth transition from concept to mass production, maintaining device integrity and regulatory compliance throughout.
We handle intellectual property (IP) and patent protection for medical device designs with confidentiality. Our process typically includes :
We sign NDAs for the confidentiality of your proprietary information.
We ensure that all your developed IP is assigned to the client.
We provide advice on patentability and assist with preliminary patent searches.
We document all design iterations and innovations to support patent applications.
We utilize secure systems for all project data and communications.
Our goal is to safeguard your innovations and ensure strong legal protection for your medical device designs.
Medical devices are categorized into classes based on their potential risks to patients and users, dictating the level of regulatory control required.
Class I devices present the lowest risk (e.g., bandages, stethoscopes) and are subject to general controls.
Class II devices pose a moderate risk (e.g., infusion pumps, surgical drapes) and require general controls plus special controls like performance standards.
Class III devices carry the highest risk (e.g., pacemakers, heart valves) and necessitate the most stringent controls, including premarket approval (PMA) due to their life-supporting, or implantable nature, or their potential for unreasonable risk of illness or injury.
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