Medical Device Design & Development

INDUSTRY PERSPECTIVES

Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis

Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations

A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

Building World-Class Global Quality Teams That Break Down Silos

Over 25 years leading global quality and regulatory organizations, I've learned that the most difficult challenges aren't regulatory or technical; they're organizational and cultural. 

Mastering Cultural Intelligence In Global Quality And Regulatory Leadership

The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. Leaders who master cultural intelligence build quality systems that leverage diversity as competitive advantage.

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WHITE PAPERS & CASE STUDIES

Choosing The Right PCD Configuration For Reliable Sterility Assurance

Accurate PCD configuration ensures sterility assurance. Learn how to align validation strategies with ISO standards, optimize cycle efficiency, and select the right BI format for EO sterilization success.

Life Sciences Corporation Implements eLogbooks Across 15 Sites

New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

Implementing A Next-Gen MES At A Fraction Of The Cost

Discover how a top medical device manufacturer accelerated product launch by digitizing assembly processes, streamlining training, and ensuring compliance.

Custom Orthodontic Aligner Manufacturer Ensures Compliance With Tulip

A pioneering orthodontic startup is transforming custom aligner production using 3D printing and software to cut time and costs in half while scaling rapidly to ensure quality and compliance.

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DESIGN COMPONENTS & SERVICES

Image Sensors for Dental X-Ray Systems

As dentists have moved away from obtaining x-ray images with film and have adopted digital imaging systems, the demand for CCD and CMOS image sensors for integration into dental x-ray systems has increased.

Flashlamp Power Supplies

Excelitas’ flashlamp power supplies are ideal for applications involving IPL aesthetic systems, excimer lasers, laser aesthetic systems, Nd: YAG solid-state lasers, pulsed lasers, and dye lasers.

Medical Silicone Processes
Medical Silicone Processes

Flexan is committed to providing the highest quality of silicone components for medical devices. Using the highest process controls alongside the most rigorous quality tools, Flexan is able to ensure patient safety and 100 percent inspection of every single component before it ships.

Optical Design and Engineering

Producing precision optical systems demands a comprehensive opto-mechanical design. II-VI Optical Systems’ team of experienced engineers work collaboratively with your team to design intricate, highly producible systems. We specialize in designing complex systems that are precisely matched with our manufacturing and assembly capabilities to deliver high yields and predictable, optimized results.

Medical Device Design Services: PTI Design

PTI has been assisting medical device companies with product design and development for over 35 years. Their design and development studio combines state-of-the-art technology with experience in bringing medical devices to market in order to deliver the most progressive and innovative designs.

Solid State Amplifier for EMC Compliance Testing: 50S1G6
Solid State Amplifier for EMC Compliance Testing: 50S1G6

AR’s solid state amplifiers are often used in medical EMC compliance test efforts. The 50S1G6 is a class A solid state amplifier which provides 50 watts of output power from 0.7 to 6 GHz.

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MEDICAL DEVICE DESIGN & DEVELOPMENT

Medical device design and development is the cyclical process of creating a device for a specific task or set of tasks, and then continuously reevaluating its effectiveness and improving upon it until the device reaches obsolescence. Design and development begins with ideation and the creation of a concept that, if found to be both fiscally and clinically viable, is then designed, engineered, and prototyped. This preclinical period includes bench testing — accomplished through simulated use of the product — and animal testing, along with any necessary redesign work.

Throughout the process, the proposed medical device, and the process by which it will be manufactured, is examined for flaws that may negatively impact the device’s safety, market viability, regulatory acceptance, customer satisfaction, usability, or profitability. Any shortcomings are corrected, and the improvements applied to the final design. Due to the wireless connectivity capabilities of many modern medical devices, cybersecurity and interoperability also must be incorporated into the design. Clinical testing is conducted, using human subjects, to further expose flaws and confirm product strengths. Once both the product design and the manufacturing process have been validated and approved by the U.S. Food and Drug Administration (FDA), production and commercialization of a device may begin.

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