Navigating Your Challenges
Transitioning from the idea stage to a fully developed medical device comes with significant challenges. We’ve identified some of the key obstacles that medical device manufacturers face:
Simplifying the Process
Our approach to medical device design is built on collaboration and efficiency. ACHB’s proven process covers six key phases that can integrating seamlessly at any stage of your project or design goals:
Planning
Develop a clear project roadmap outlining goals, timelines, and critical resources needed to achieve the design and development objectives.
Planning
Proof of Concept
Validate the feasibility of your design concept through prototypes or simulations to ensure it meets initial technical and functional requirements
Proof of Concept
Engineering Verification Testing
Perform detailed testing to confirm that the engineering design functions as intended and meets all technical specifications.
Engineering Verification Testing
Design Verification Testing
Verify that the final design matches the user's needs and requirements, ensuring it can be successfully manufactured and performs as expected.
Design Verification Testing
Regulatory Compliance
Ensure the product adheres to all industry standards and regulatory requirements, including FDA and ISO certifications.
Regulatory Compliance
Product Verification Testing
Test the final product to confirm that it meets all performance, safety, and compliance requirements before mass production or release to market.
Product Verification Testing
Prototyping and Iterative Development
Innovation in sophisticated devices often requires rapid prototyping and refinement. Our state-of-the-art facility supports iterative prototyping to transform your concepts into fully functional life science equipment and medical devices. Our experienced engineering team helps guide the transition from prototype to completed product, ensuring scalability and market-readiness.
High-Precision Engineering
Precision, quality, and biocompatibility are crucial for life science and medical devices to meet strict regulations and succeed in the market. We specialize in integrating advanced mechanical components into complex geometries to develop high-quality, functional medical-grade devices. We work with Class I and II devices that require cutting-edge components, such as:
Commitment to Quality
Our ISO 13485 certified facility and robust quality management systems ensure precision at every step of the development process. The 6-phase development approach we apply to your project enables us to produce compliant, high-performance devices across industries, including:
Medical Devices
Our commitment to quality in medical devices ensures that every product meets stringent regulatory standards, delivering reliability and safety healthcare providers and patients alike.
Medical Devices
Life Science
We pledge precision and innovation in our laboratory equipment, understanding that accuracy is critical in scientific discovery and medical diagnostics, ensuring your research is never compromised.
Life Science
Robotics
In robotics, our quality commitment translates to durable, high-performance automation that pushes the boundaries of efficiency and functionality, tailored to meet the unique demands of your operations.
Robotics
Food & Beverage
For food and beverage equipment, we uphold the highest standard of hygiene and durability, ensuring that our machinery supports food safety, enhances productivity, and maintains the integrity of your products.
Food & Beverage
Experts In Component Design
By partnering with ACHB for your component design needs, you can ensure your designs are optimized for manufacturability, cost efficiency, and scalability, setting the stage for successful production and long-term performance. Contact our team to learn more about how we can support your next project.