Design, Build, and Test Precision Medical Devices
Medical Device Design and Development
We specialize in the innovative development of electromechanical FDA classified devices.
Our regulatory and quality foundations have been developed through our rigorous R&D processes for medical device design and development. They’ve been scrutinized through acquisitions and audits, and have been praised through both. Our experience and expertise in developing medical devices through regulated processes is crucial to maintaining speed and efficiency resulting in a more robust process and better products.
Comprehensive Design Controls For Success
We don’t just say it; we do it. Our medical device start-up mentality helps us think and act differently, which gives advantages to clients both large and small.
Understand the Standards
Unsure of what standards your device needs to meet? Designing and testing to the appropriate standards can be confusing, time-consuming, and expensive. We have the depth of understanding to know what is required and with a quick call, we can give you an overview of what you’ll need.
- Certified to ISO 13485:2016
- Compliant to 21 CFR Part 820
- DHFs
- Risk Management
- FMEAs (Usability, Design, Process)
- Verification Testing
- Validation Testing
- Reliability Testing
- Electrical Safety Testing (IEC 60601-1)
- EMC Testing (IEC 60601-1-2)
- Emissions Pre-Screening
- IEC 62304 Medical Device Software
- Formative & Summative Usability Testing
- Environmental Testing
- 510(k) Submissions
IEC 60601 EMC & Electrical Safety Testing
One of the most frequent inquiries we get is about understanding electrical safety and emissions testing. We’ve gone through the standards extensively and we can help you understand what’s required and what’s not.
IEC 62304 Medical Device Software Development
Our in-house medical device software is written per IEC 62304. We can help get yours under compliance, either by working with us or just some simple guidance and review.
FMEAs
Independent review of design, process, and usability failure modes is an important step in medical device development. Our talented team can tackle your FMEAs, giving you confidence that a broad range of thinking has reviewed and influenced your design.
THE PROCESS
Design Controls For Success
01
Inputs and Outputs
Thoughtfully conceived design inputs guide our medical device product development. This leads to establishing design outputs, defining the design intricacies, specifying the components, and determining the assembly processes. This is where a medical device really starts to come to life.
Tie it all together
Here's what's next
03
Verification and Validation Testing
It’s time to prove we’ve met our input and risk requirements. Our thorough and statistically significant V&V testing programs will demonstrate to the FDA that you’ve mitigated risks and met your design objectives. This is where you prove you are doing what you said you would do.
WHAT WE'VE DONE
Our Work
An Experienced Viewpoint
Medical Device Design and Development Reviews
We are experienced medical device designers, engineers, manufacturers, and regulatory experts. With all of the testing and regulation surrounding medical device design and development, it pays to have outside experts offer other viewpoints, giving you peace of mind to keep moving forward.