Medical Devices

Missions that Matter

Class II and III medical devices are the backbone of our system for healing the sick and injured and for identifying disease in time to do something about it.

The core technologies are always fascinating, and technical execution must be precise.

We feel honored to help leading life science companies develop, verify, and sustain the hardware and firmware that deliver on the promise of supporting and restoring human health.

The Bar is High

Successful medical devices must meet the rigorous requirements of providers, administrators, regulatory bodies, and most of all, patients.

Performance and quality are paramount, and reliability must be beyond question. Every design choice, material selection, and manufacturing process is mission critical. 100% right-fit solutions are a must – there are no shortcuts and no room for error.

Finding the right people for a new medical device mission can be really hard – finding a team to help solve a sustaining challenge can feel almost impossible. For over 20 years, AC has specialized in providing the right medical grade engineering teams when you need them most.

Missions that Matter

Class II and III medical devices are the backbone of our system for healing the sick and injured and for identifying disease in time to do something about it.

The core technologies are always fascinating, and technical execution must be precise.

We feel honored to help leading life science companies develop, verify, and sustain the hardware and firmware that deliver on the promise of supporting and restoring human health.

Medical Devices - Defib Defibrillator

The Bar is High

Successful medical devices must meet the rigorous requirements of providers, administrators, regulatory bodies, and most of all, patients.

Performance and quality are paramount, and reliability must be beyond question. Every design choice, material selection, and manufacturing process is mission critical. 100% right-fit solutions are a must – there are no shortcuts and no room for error.

Finding the right people for a new medical device mission can be really hard – finding a team to help solve a sustaining challenge can feel almost impossible. For over 20 years, AC has specialized in providing the right medical grade engineering teams when you need them most.

Medical Devices - Defib Defibrillator

Feeling Over committed &
Resource Constrained?

Design for Safety & Regulatory

Product safety and regulatory compliance is ensured by application of Quality Management (QMS), Product Lifecycle Management (PLM), and Product Data Management (PDM) systems, often proprietary and built over many years of tailoring to specific products and processes.

Though the complexity of these systems can be intimidating to new contributors, AC is expert at adapting to new design control environments quickly, efficiently and thoroughly. Our teams are well versed in design, testing and documentation within Medical Device 21 CFR 820, ISO13485, ISO 9000/9001 and IEC60601.

We integrate seamlessly to our customers’ design / documentation workflow, ensuring that Design History Files (DHF) and Device Master Records (DMR) are created and maintained with the fidelity and completeness required for smooth process through regulatory examination.

Maximum Reliability / Minimum Risk

Reusable medical devices must perform for years at high reliably under harsh conditions.

Design and materials selection choices must anticipate increasingly aggressive sterilization protocols, component EOL issues and shifting regulatory standards.

We’ve delivered on these challenges for 21 years and help our customers see around corners for success in the long haul.

Design for Safety & Regulatory

Product safety and regulatory compliance is ensured by application of Quality Management (QMS), Product Lifecycle Management (PLM), and Product Data Management (PDM) systems, often proprietary and built over many years of tailoring to specific products and processes.

Though the complexity of these systems can be intimidating to new contributors, AC is expert at adapting to new design control environments quickly, efficiently and thoroughly. Our teams are well versed in design, testing and documentation within Medical Device 21 CFR 820, ISO13485, ISO 9000/9001 and IEC60601.

We integrate seamlessly to our customers’ design / documentation workflow, ensuring that Design History Files (DHF) and Device Master Records (DMR) are created and maintained with the fidelity and completeness required for smooth process through regulatory examination.

Andrews Cooper - Medical Devices

Maximum Reliability / Minimum Risk

Medical devices must perform at the highest levels of reliability under the most demanding of conditions, in many cases for years of expected continuous service.

AC helps deliver maximum reliability at minimum risk by systematic, disciplined application of manufacturing focused risk reduction methods: Failure Modes and Effects Analysis (FMEA), Design Requirements Traceability, and Post-market Surveillance performance testing are key to smooth product introduction and sustained lifecycle performance.

We’ve helped our customers deliver on these challenges for 21 years, and we’re dedicated to helping you see around corners for long haul product success.

Medical Devices - Defib Defibrillator

Need a team of proven performers,
purpose built for what you build?

V&V / Test Automation

AC puts V&V testing squarely at the center of every medical device development.

Ensuring that the product’s design and performance fulfills both regulatory and functional requirements is paramount to mission success. AC has built teams that are not only expert at V&V, but also embrace the challenges & rigor of documenting product success.

The ability to design / build the required automated test instruments ensures pace, appropriateness, and quality of results.

V&V / Test Automation

AC puts V&V testing squarely at the center of every medical device development.

Ensuring that the product’s design and performance fulfills both regulatory and functional requirements is paramount to mission success. AC has built teams that are not only expert at V&V, but also embrace the challenges & rigor of documenting product success.

The ability to design / build the required automated test instruments ensures pace, appropriateness, and quality of results.

Looking for a partner dedicated to
100% Mission success?

Analog up front / Digital in the back

In monitoring patient status and clinical response, minute analog signals must be captured with high fidelity in the most challenging of conditions.

Through many years of developing ECGs and other body contact devices, Andrews Cooper has built singular expertise in acquiring, digitizing, processing and presenting low level patient signals in high noise environments with life critical accuracy & precision.

AC teams get to know the system’s data streams so well that we often contribute to the development of the algorithms core to mission success.

Level Up

Almost without exception, category-defining medical devices are generational – each new version builds on the performance and quality of the previous.

AC Customers know that in order to stay ahead, they must continuously level up their products’ design, user experience, and capability.

Over the last 21 years, we’ve had the honor to contribute to numerous multi-generational developments of life-critical product lines, and we’ve solidly learned the rhythms of leveling up.

Analog up front / Digital in the back

In monitoring patient status and clinical response, minute analog signals must be captured with high fidelity in the most challenging of conditions.

Through many years of developing ECGs and other body contact devices, Andrews Cooper has built singular expertise in acquiring, digitizing, processing and presenting low level patient signals in high noise environments with life critical accuracy & precision.

AC teams get to know the system’s data streams so well that we often contribute to the development of the algorithms core to mission success.

Andrews Cooper - Medical Devices

Level Up

Almost without exception, category-defining medical devices are generational – each new version builds on the performance and quality of the previous.

AC Customers know that in order to stay ahead, they must continuously level up their products’ design, user experience, and capability.

Over the last 21 years, we’ve had the honor to contribute to numerous multi-generational developments of life-critical product lines, and we’ve solidly learned the rhythms of leveling up.

Medical Devices - Defib Defibrillator

We’ve got your back.