MEDICAL DEVICE DEVELOPMENT SERVICE
At AJProTech, we specialize in delivering unparalleled solutions for your IoT business. We offer a comprehensive range of top-notch services that cover every aspect of bringing your ideas to life and turning them into cutting-edge smart products. concept to production, we have the expertise and experience to handle it all.
Whether you need assistance with standard hardware development or are seeking exclusive, hard-to-find solutions such as semiconductor design and rapid prototyping, we have you covered. Our engineers are well-versed in the latest technologies and industry best practices, ensuring that your IoT products are of the highest quality and innovation.
MEDICAL DEVICE DEVELOPMENT & ENGINEERING SERVICES
HOW TO START
FEASIBILITY STUDY
AJProTech has developed an innovative way to streamline the manufacturing process of IoT devices. The IoT platform is the result of the combined expertise of AJProTech engineers and is a fast and easy way to validate and assemble various types of sensors on our foundation. It is equipped with high-quality hardware and software, integration with displays and various sensors, and data transmission to the web and mobile applications.
This platform is designed to reduce production costs, speed up the process, and provide a secure and reliable product with a user-friendly interface and intuitive navigation. It can be customized to meet your needs and incorporates a variety of components, both wired and wireless connections, firmware, and software that are widely available and commonly used.
BUILD YOUR DEVICE FASTER
AJProTech has developed an innovative way to streamline the manufacturing process of IoT devices. The IoT platform is the result of the combined expertise of AJProTech engineers and is a fast and easy way to validate and assemble various types of sensors on our foundation. It is equipped with high-quality hardware and software, integration with displays and various sensors, and data transmission to the web and mobile applications.
This platform is designed to reduce production costs, speed up the process, and provide a secure and reliable product with a user-friendly interface and intuitive navigation. It can be customized to meet your needs and incorporates a variety of components, both wired and wireless connections, firmware, and software that are widely available and commonly used.
Medical device development process
Feasibility
study
- Solution research
- Product Specification
- Component selection
- Early industrial Design
- Cost estimate
Proof of concept
“Work like” prototypes using development kits
Early customer feedback
PROVE CORE TECHNOLOGIES
2 – 3 months
Engineering
Validation
- Detailed engineering
- Industrial Design
- Electronics development
- Embedded firmware
- Mechanical design
Engineering samples using rapid prototyping, 10–50 pcs
Customer Beta testing
Pre-compliance testing
Second iteration, if needed
EVT
ENGINEERING SAMPLES MEET SPECS
5 – 6 months
Design
Validation
- Select Manufacturer (CM)
- Design for Manufacturing
- CMF (Color, Materials, Finishing)
- Electronics design ECO
- Firmware / Software finalization
- DFM for Mechanical parts
Tooling for Mechanical parts
CM does product prototyping using tooling, 50–100
units
Compliance tests (FCC, UL, CE)
Deliver samples to beta testers
DVT
PRE-PRODUCTION SAMPLES READY
4 – 5 months
Production
Validation
- Supply chain optimization
- Final tooling for all parts
- Prepare Functional tests
- Create test jigs
- Fault and yield review
- Order parts for first batch
Setup manufacturing process
CM applies mass-production techniques, 500–1000+ units
Final compliance tests
Deliver product to early backers
PVT
PRODUCTION PROCESS VALIDATED
3 – 4 months
10 YEARS OF EXCELLENCE
AJProTech extends beyond delivering exceptional IoT solutions for our clients. We believe in fostering a collaborative community where knowledge is shared and opportunities for growth are nurtured. By freely sharing our expertise and insights, we aim to contribute to the collective advancement of the IoT industry and inspire others to reach new heights.
AJProTech has developed an innovative way to streamline the manufacturing process of IoT devices, cementing our position as a leader in the IoT industry. Our expertise in IoT development services has garnered us the esteemed recognition of being a highly rated company, across various platforms, including being trusted partners by Clutch with a 5-star rating.
Alex Gudilko, the CEO and Founder of AJProTech, regularly shares his insights on the hard tech industry in Forbes. With a focus on emerging technologies, engineering advancements, and business strategies, Alex's articles provide valuable perspectives for navigating the complexities of the hard tech sector. Through his contributions, he aims to foster understanding, inspire innovation, and empower professionals in the industry.
Frequently asked questions
What are medical device development services?
Medical device development services encompass a comprehensive range of activities aimed at creating new medical products or improving existing ones. These services include device design, engineering, prototyping, and manufacturing. Companies like AjProTech offer expertise in navigating the development process, ensuring compliance with regulatory requirements, and facilitating the journey from concept to device to market.
What is the typical development process for a medical device?
The development process for a medical device typically involves several phases: ideation, feasibility, design and development, verification and validation, and finally, production. Each phase is crucial for ensuring that the device meets both technical specifications and regulatory compliance. AjProTech follows a structured approach, incorporating risk management practices to mitigate potential issues early in the device development process.
How does AjProTech ensure regulatory compliance in medical device development?
AjProTech utilizes a robust quality management system that aligns with the FDA guidelines and other regulatory requirements. Their team stays updated on the latest standards in the medical device industry and employs rigorous documentation practices throughout the development process. This attention to detail not only helps in achieving regulatory compliance but also builds trust with stakeholders.
What role does prototyping play in medical device design?
Prototyping is an essential step in medical device design, allowing developers to create tangible models of their concepts. This phase helps in testing functionality, usability, and overall design before moving into full-scale manufacturing. AjProTech’s prototyping services enable clients to refine their ideas and gather valuable feedback from potential users, ultimately leading to better final products.
What types of medical devices can AjProTech develop?
AjProTech specializes in a wide range of medical devices, including diagnostic tools, wearables, and telemedicine gadgets. Their expertise spans various sectors within the medical device development industry, catering to both portable and fixed devices. Whether it’s a bluetooth enabled tracker or complex health analyzer.
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