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.
Medical Device Engineering
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
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)
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...
Insights from Greenlight Guru’s 2023 MedTech Industry Benchmark Report
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...
Using Creo to Meet Stringent Regulatory Requirements in Medical Device Engineering
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...
Blog: Leveraging PTC’s Integrity Platform for IEC 62304 Compliance
SPK and Associates leverage PTC’s Integrity platform to help Medical Device companies develop software efficiently while achieving IEC 62304 compliance.
Application Management Reduced Testing Time from Days to Under One Hour
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...
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...
Achieving the Speed of Innovation and Maintaining Compliance in the Medical Device Industry
Innovation is essential for staying ahead of competition in all industries, but especially in healthcare. Staying up to date with new technologies and compliance needs can improve outcomes for patients. The best way to ensure compliance is by utilizing the proper...
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....
Building Resilience in Healthcare IT Infrastructure through Cybersecurity Strategies
Cybersecurity is important in every industry but is especially vital in healthcare. Safety, compliance, and data protection become more important than ever. With cyber attacks on the rise, protecting sensitive patient data has become a main priority. Let’s explore...