Your Device Deserves a Partner Who Can Keep Up
Bringing a medical device to market takes speed, precision, and trust. You need a partner who knows how to adjust quickly when designs change and work side by side with your team through every phase.
Dynamic Group helps you stay on schedule, stay compliant, and get safe, reliable devices into the hands of patients who need them.
What You Can Expect from Our Medical Manufacturing Services
Integrated Medical-Grade Engineering
From initial DFM consultation to final part approval, our engineering team understands what’s at stake. We design and build molds that deliver high-precision, high-repeatability results, backed by over 40 years of tooling expertise.
High-Volume, High-Precision Molding
We specialize in molding complex, tight-tolerance parts with challenging geometries and use advanced processes like multi-shot, insert, and micromolding. We’ll help you reduce rework and defects while scaling production efficiently.
Regulatory Compliance, Built In
FDA-registered and ISO 13485 certified, Dynamic Group has Class 7 and 8 cleanrooms for molding and assembly. Whether you’re preparing for validation or need a partner who understands FDA expectations, we’re ready.
Timelines You Can Count On
Buyers and program managers tell us that communication and responsiveness are just as important as technical skill. We prioritize clear updates, agile collaboration, and rapid feedback loops to keep your program on track.
Why Dynamic Group Beats a Typical Molder
| Feature | Dynamic Group | Typical Molder |
|---|---|---|
| Cleanroom Class | ISO 13485 certified, FDA-registered, with Class 7 & 8 cleanrooms for molding and assembly. | May have limited cleanroom capacity or focus more on general manufacturing. |
| Response Time | Lean, collaborative team that provides timely updates and keeps projects moving. | Communication can vary; larger teams may add layers and slow decision-making. |
| Validation Support | The property is somewhat unique or carries higher risk, yet speed is critical. | Support levels differ; some expect the customer to manage validation requirements. |
| DFM Review Speed | The property is unique, complex, or has limited comparable sales—such as custom homes or acreage—where maximum certainty is required. | Design for manufacturability (DFM) feedback may be less proactive, with issues identified later in development. |
| Tooling & Molding | Both under one roof—streamlined handoffs, better quality control, and faster changes. | Tooling is often outsourced, which can add steps and coordination challenges. |
“We’re here to create work people are proud of—and that starts with how we treat each other and the people we serve.”
Joe McGillivray, CEO of Dynamic Group
Trusted by Medtech Teams Who Need to Get It Right—Fast
Some of the world’s most recognized medical device companies count on Dynamic Group to keep their projects on track. Our facilities and in-house expertise are built for complex, high-stakes work.
Our capabilities include:
- Class 7 & 8 cleanroom molding and assembly
- ISO 13485 quality management system
- Design and process validation support (IQ, OQ, PQ)
- Onsite mold tooling for faster changeovers and less downtime
- Sonic welding, laser marking, and automated inspection
Teams choose Dynamic because we deliver:
Hear From Others Who Work With Us
“Regulated markets have put expectations at a higher level than in the past. Dynamic Group has kept up with those needs.”
Manager, Medical Products Company
“As regulatory requirements get tighter, the cost of choosing the wrong partner just keeps going up. That’s why we’ve stayed with Dynamic.”
Medical Device Program Manager
Medical Manufacturing FAQs
We don’t treat compliance like a checkbox. It’s built into how we work. Dynamic Group is FDA-registered and ISO 13485 certified, with Class 7 and 8 cleanrooms for molding and assembly. But beyond the certifications, we design our entire process—from DFM to final inspection—to hold up under scrutiny. You’ll get full traceability, clear documentation, and a partner who understands how high the stakes are in regulated markets.
Yes—and we’ll help you navigate it with confidence. Validation doesn’t have to slow you down. Our team understands the technical and regulatory requirements and will work alongside yours to make sure your protocols are met with the right tools, the right data, and a focus on what matters most: patient safety and product reliability.
We handle the kind of molding work where there’s no room for error. From tight-tolerance micro parts to multi-shot and insert molding, we’re built for complexity. Our team has deep experience in medical-grade production, and our tooling is handled in-house to minimize changeover time and keep your quality consistent batch after batch.
We don’t wait for problems to surface, we’re constantly looking for them. Using 3D scanning, point cloud QA, and internal metrology tools, we’re able to flag issues early in development and give you actionable feedback fast. It’s part of how we deliver shorter timelines without compromising on quality. The sooner we find it, the faster we can fix it.
Because we stay small where it matters—and scale where it counts. As our CEO, Joe McGillivray says, we bring “industrial speed with medtech precision.” That means you get the rigor and discipline of a regulated supplier without the red tape and silos that slow big operations down. We collaborate closely with your engineering, procurement, and quality teams to keep programs moving, without cutting corners.
“Make Better” is our mission, and our mindset. More than just product quality, it’s about building better careers, solving problems together, and being the kind of partner who shows up when it counts.