Resources

Dual and multi-sourcing strategies for medical device manufacturers

How do you actually implement dual or multi-sourcing without introducing new risks around validation, cost or compliance?

EU Medical Device Regulation - traceability by design and the importance of building compliance into every medical component

How important is multi-sourcing in medical device manufacturing?

Many medical OEMs are increasingly exploring multi-sourcing strategies when planning their manufacturing operations.

What is ISO-13485 compliance-by-design?

Forward-thinking manufacturers are adopting a compliance-by-design mindset by embedding ISO 13485 principles from day one.

What are the benefits of small wave springs?

Wave springs have the potential to address many of the challenges faced by modern medical device designers.

Which medical devices are best suited for wave springs?

Wave springs offer a compelling alternative to traditional coil springs.

What is a wave spring?

Wave springs are an innovative new component in modern medical devices.

How to scale medical components and devices from prototype to production

Scaling a medical device from prototype to production introduces a distinct set of challenges that extend far beyond proof..

The hidden cost of failing to design medical devices for manufacture

When that design isn’t engineered for manufacture, costs inevitably rise, delays increase and compliance risks multiply.

Why compliance-by-design is non-negotiable in medical device manufacturing.

Patient safety and clinical efficacy depend upon stringent regulatory oversight.