Design, Prototype, Test and Manufacture Medical Devices
Medical Device Design and Development
We design, prototype, test and manufacture medical devices within our ISO 13485 quality system in Cary, North Carolina. Mechanical, electrical, firmware, software, industrial design, human factors and contract manufacturing work as one team, so nothing gets lost in a handoff. We have taken devices from early concept through FDA clearance, and our process has held up through startup acquisitions, due diligence and every audit.
Creative Engineering, With Design Controls Built In
Early in a program, creativity and experience set the direction. We explore ideas, build prototypes and test them fast, because that is where the right answers originate. Design controls are there from the start, scaled to fit each stage, so when the design firms up the documentation is already in place and ready for FDA. Rigid enough for FDA, flexible enough for real engineering.
Certified to ISO 13485 by Intertek
Understand Medical Device Design Standards
Unsure of what standards your device needs to meet? Designing and testing to appropriate medical device standards can be confusing, time-consuming and expensive. We have the depth of understanding to know what is required. 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
- Design History File (DHF)
- Risk Management (ISO 14971)
- 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.
KEY DESIGN HISTORY FILE (DHF) COMPONENTS
Medical Device Design Controls
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.
OUR PROCESS
A Medical Device Program Guide
Every program is different, but the order rarely changes, because the order is how we mitigate risk early, when changes are still easy to make. Most programs reach design freeze in about 9 to 24 months.
Planning and De-Risking
Requirements first, then system architecture with a preliminary target BOM cost, the regulatory path and the software safety class. We prove the riskiest technology on the bench before we get too deep. Usually one to three months.
Design to Alpha
Mechanical, electrical, firmware, software and industrial design run in parallel. We start on the bench, then build a looks-like, works-like Alpha. We pre-screen EMC in house so surprises show up early. Typically 5 to 12 months.
Beta and Design Freeze
Alpha lessons roll into Beta updates, then we build and test it again. Drawings, BOMs, and assembly and test procedures get written as we build, and those build documents become the DMR. When the Beta proves out, the design freezes. Typically 3 to 6 months.
Final Adjustments and V&V Builds
Beta findings drive final modifications. Then we build the V&V units for real, from released documents and with enough volume to start stressing the manufacturing systems. If a tolerance, drawing callout, procedure or fixture needs to be addressed or modified, we’d rather find out here, before the transfer to manufacturing.
Verification and Validation
Function, environmental, reliability and software testing happen in our lab, and IEC 60601, EMC, biocompatibility and shipping tests at accredited labs. The test reports feed straight into your regulatory submission. Typically 3 to 5 months.
Transfer and Pilot Production
Manufacturing plan, supplier approvals, quality plans, inspection criteria, fixtures and pilot builds. The pilot builds start to show what the product really costs to make. From launch volumes to full production, we ramp in planned steps that match your sales needs.
One Program Manager, Weekly Reviews
Every program gets a dedicated program manager and weekly or biweekly reviews. You always know where the schedule and budget stand, and when scope changes, the cost and time impact is promptly communicated.
Use Our ISO 13485 System
You don’t have to build a quality system while you build a product. Clients can adopt our ISO 13485 system, certified by Intertek, and run their design controls inside it from day one.
You Own the Design
Drawings, source code and design files belong to you. When the program is done, you own the device and everything it took to make it.
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.
Frequently Asked Questions
What does medical device design and development include?
Everything it takes to go from an idea to a device you can sell: requirements, engineering, prototypes, design controls, risk management, verification and validation, and transfer to manufacturing. We do all of it under one roof, with ISO 13485 contract manufacturing in house.
How long does it take to develop a medical device?
Most programs reach design freeze in about 9 to 24 months, depending on complexity and where you start. Verification and validation testing typically takes another 3 to 5 months before the FDA submission. FDA review time varies and is outside anyone’s control.
How much does medical device development cost?
A first working prototype usually runs a few hundred thousand dollars. Taking a complex Class II device through design controls and V&V can run from several hundred thousand to several million. Every program gets a line-item plan, so you see the budget before you commit.
When do design controls start?
From the start, scaled to the stage of the program. Early on, creativity and experience lead and the documentation stays light. As the design firms up, the controls tighten, so the design history file is complete when you need it.
Is your design and development process ISO 13485 certified?
Yes. We are certified to ISO 13485:2016 through Intertek under the Medical Device Single Audit Program (MDSAP), and the certification covers design and development, not just manufacturing. The design controls we write for your project, and the SOPs behind them, are audited by an independent registrar and by our customers. When a submission review or an FDA inspection looks at your design history file, it was built on procedures that have already held up to outside audits.
Why does it matter if a design firm is ISO 13485 certified?
Your design history file is only as good as the process that created it. Many design firms say they follow design controls or are ISO 13485 compliant, but nobody outside has audited their procedures. The gaps show up late, in an FDA request for more information, a notified body audit or an inspection, and fixing them means design control remediation. In software and firmware, remediation takes real time and budget, often more than doing it right the first time would have. We know, because we do remediation for clients whose first design firm skipped it. A certified design process means the procedures were checked before your project started.
Can we audit your quality system?
Yes, any time. Our customers audit us regularly, and we welcome it. Seeing our procedures, records and floor firsthand is the best way to know your device is in good hands.
Do I need my own ISO 13485 quality system?
No. Clients can adopt our ISO 13485 quality system, certified through Intertek under the Medical Device Single Audit Program (MDSAP), and write their design controls inside it. That saves you from building a quality system while you build a product.
Can you help with IEC 60601 and IEC 62304?
Yes. We design to IEC 60601 electrical safety and EMC requirements from the start and pre-screen EMC in house, so formal testing goes smoothly. Our software and firmware are developed to IEC 62304, including Class B and C software.
Can you help with medical device cybersecurity?
Yes. Cybersecurity is built in from the start: a cybersecurity risk assessment and threat model during design controls, secure firmware and software, and the software bill of materials and documentation FDA expects in a submission. Independent penetration testing happens during V&V.
Can Blur manufacture the device after development?
Yes. We run ISO 13485 contract manufacturing in house, from pilot builds and launch volumes to full production, ramped in planned steps that match your sales.
By Keith Gausmann, Partner, Blur Product Development. Last updated November 6, 2026.