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Biomed/Medical Devices

The diversity of firms in the biomed industry is incredible. Whether you’re making implants, exoskeletons, rehab and recovery equipment, imaging systems, diagnostic machines or artificial organs, design and development are critical to your success. You’ve got to manage a vast network of suppliers and partners, and the regulatory environment for developing projects is complex. Plus, the legal liability can be massive if things aren’t done right.

Meeting FDA Design Controls and Quality System Regulations, ISO 13845 and ISO 14971 requirements are challenging, plus you’ve got other governmental regulations to navigate. And, as if getting through the R&D phase wasn’t arduous enough, garnering FDA and governmental approval can take years.

Not only that, you face unique production challenges. Working with extremely small components, exotic materials, cutting edge, automated manufacturing technologies, customized equipment, and one-off products require both precision and flexibility in your process. And when working with specialized, high performance suppliers who have design responsibility, you have to get everyone on the same page.

Clear communication among all those involved in design, production, and inspection is integral to your success. GD&T fosters and enables that clarity and ensures that your tolerances are as tight as they need to be at the critical points, while staying as loose as possible elsewhere to keep production costs low.

Experience is what led GD&T Basics to develop our unique instructional approach. We’ve worked with some of the leading biomed firms in the world, including AstraZeneca, Medtronic, and Thermo-Fisher Scientific. We know that biomed companies have workforces filled with highly specialized, highly skilled people, but GD&T may not be a part of their existing knowledge base.

We know how to work with people at the top of their field, because we’re at the top of ours.

Our program not only teaches students what they need to know of the ASME 14.5Y standard, but also provides them the context needed to understand how the part will function, and how it’ll be made, tested and inspected. Understanding the context of an entire project helps your people communicate with suppliers and clients, and avoid problems before they start.  

We understand the demands of governmental regulations, the challenges of acquiring FDA approval and the consequences of getting it wrong. We know how to ramp up our training programs to match any influx of new talent as your organization grows. Our online coursework combined with live training is tailor-made to teach your people how to get it right. We can even customize our training to incorporate your drawings and the subset of GD&T applicable to your business. And, we’re happy to work with you and your suppliers to build a training regimen that maximizes the effectiveness of your entire design and production process.

Contact us today and we’ll work together to build your team’s perfect training program.