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Medical Device Engineering

PLM: Automate your Product Development Compliance Process

PLM: Automate your Product Development Compliance Process

Developing new and innovative products is essential for companies to survive and thrive -- however safety can never take a backseat to innovation. That is why many companies, like those in the Medical Devices, Aeronautics and Automotive industries, have strict...

How PLM Enables Innovation Without Risking Compliance

How PLM Enables Innovation Without Risking Compliance

As technology has advanced, it's become more complex -- and with complexity comes the issue of tracking and monitoring the different processes and their corresponding data. In non-critical applications, the extent of this reporting is often minimal. However, in...

Accelerating Product Development with Engineering Operations

Accelerating Product Development with Engineering Operations

What is Engineering Operations (EngOps)? Why do you need it, and how do you effectively deploy it?There’s a strange interplay between IT and engineering teams in most firms. That’s because the tech stack that engineers need to design, build, test, and release products...

The State of Digital Quality Maturity in Pharma and Medtech

The State of Digital Quality Maturity in Pharma and Medtech

Organizations in the medical, pharmaceutical, and life science industries are constantly adapting to their field’s rapidly changing technology and regulations. This continuous adjustment can become exhausting. Between this burnout and being unsure if your technology...

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...

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....