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Medical Device Engineering

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....

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...