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...
SPK and Associates co-founder Chris McHale speaks with PLM expert Oleg Shilovitsky, founder of BeyondPLM.com, to get his insight on the difficulty of BOMs across engineering disciplines.
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...
A COMPLETE OVERVIEW OF SMART MEDICAL DEVICES, THEIR DEVELOPMENT AND THEIR COMPLIANCE CONSIDERATIONS. While the Internet of Things offers great opportunities both for businesses and consumers, compliance and security must be thought through carefully from the very...
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...
Unlocking the Power of Collaboration and Efficiency Tired of trying to overcome the pain points of traditional software development methods? Frustrated with slow project delivery? Struggling with team collaboration? Version control nightmares? Worry no more. You can...
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...
In a year of unexpected twists, the medical technology (MedTech) industry finds itself amidst shifting sands. So, Greenlight Guru’s 2023 MedTech Industry Benchmark Report is a treasure trove of insights into MedTech trends and the landscape. Let's deep dive into some...
All medical device manufacturers understand that precision, safety, and regulatory compliance are vital in their industry. Without these precautions, individuals could be harmed. These strict requirements and extended life cycles often make the time between designing...
SPK and Associates leverage PTC’s Integrity platform to help Medical Device companies develop software efficiently while achieving IEC 62304 compliance.
When a global leader in infusion therapy, pain management technology, and support was developing more complex systems, they required an effective design control solution to support those efforts. SPK stepped in to help the medical company implement Windchill...
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...