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Medical Device Engineering

Introduction to ISO 14971:2019 for Medical Device Compliance

Introduction to ISO 14971:2019 for Medical Device Compliance

Navigating the complexities of ISO 14971:2019 can be challenging. But, with this eBook presented by SPK and Associates and PTC, you're taking the first step towards expertise in medical device compliance. What's In The ISO 14971:2019 eBook This comprehensive guide...

2022 Guide: Software as a Medical Device (SaMD)

2022 Guide: Software as a Medical Device (SaMD)

What is software as a medical device? Software as a medical device, or SaMD is software that is intended for one or more medical purposes. This software performs those purposes without being part of a hardware medical device.  SaMD devices also need to meet the...

Optimizing Solidworks PDM Implementation

Optimizing Solidworks PDM Implementation

When multiple employees of a Fortune 100 medical equipment manufacturing company reached out to us for support with workflow functions and permissions, we knew there was a better way.  Rather than fixing the issues that would inevitably keep occurring with their...

Accelerating Medical Device Development with the Digital Thread

Accelerating Medical Device Development with the Digital Thread

The medical device industry is one of the most regulated industries due to the importance of the products they manufacture. Efficiently producing high-quality products that comply with regulatory standards is the key to successful medical device manufacturing....

Creo Composites Design & Manufacturing Capabilities

Creo Composites Design & Manufacturing Capabilities

Engineers typically have a few distinct materials to work with when designing and manufacturing parts. Composite design allows them to combine two or more varying materials to create a new one. This new material is often sustainable and used to design structures. This...

ISO 9001: Quality Management in Medical Device Manufacturing

ISO 9001: Quality Management in Medical Device Manufacturing

Ensuring medical device quality is critical. So, you’ll need to understand and meet ISO requirements to appeal to potential buyers and streamline management. In this blog, we discuss ISO 9001 as it relates to medical device manufacturing, what your business can do to...