Frequently Asked Questions

1. What types of medical devices do you specialize in?

We work across a broad range of device categories, including disposables, catheter-based devices, electromechanical instruments, diagnostic platforms, and automation systems. We tailor our approach to each project’s unique technical and regulatory needs.

2. What services do you offer?

We provide full-service product development, prototyping, regulatory documentation support, pilot and low-volume manufacturing, and custom automation systems. You can engage us at any stage—from napkin sketch to clinical trial and beyond.

3. Are you ISO 13485 certified?

Yes, Northeast Biomedical’s Quality Management System is ISO 13485:2016 certified through DEKRA. Our development process adheres to all applicable medical device quality and regulatory standards.

4. Do you only work with startups?

No. While we love supporting startups, we also work with mid-size companies, OEMs, and global MedTech firms. We adapt our engagement model based on your team's size, timeline, and capabilities.

5. Do you offer contract manufacturing services?

Yes, we provide low-volume and pilot-scale manufacturing in both standard and cleanroom environments. Our services are ideal for early-stage production, clinical studies, and limited market releases.

6. Can you support just one phase of development?

Absolutely. Whether you need early feasibility work, prototype builds, design verification, or manufacturing support, we can plug into your process at any stage.

7. How do you ensure confidentiality?

We take client confidentiality seriously and are happy to sign NDAs at the start of a conversation. All internal processes and file systems are managed securely.

8. Do you develop custom laboratory or test systems?

Yes. We design and build custom equipment for research, testing, and production—ranging from automated test rigs to catheter reflow systems and syringe mixers.

9. Where are you located?

We’re based in Tyngsboro, Massachusetts, just north of Boston, with easy access to major medical and engineering hubs in the region.

10. How do I get started?

Contact us through the form on our website or call us directly. We’ll schedule a brief discovery call to learn more about your project, goals, and how we can help.

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Whether you're exploring concepts or scaling manufacturing, we're here to help. Use the form to connect with our team—we’ll take it from there.