Resources to Help Accelerate Your Product Development
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The Power of Trend Analysis in Drug Development with eQMS Platforms
There is an intrinsic value of identifying trends in data for medtech manufacturers. Yes, the prospect of avoiding scrutiny from federal auditors is a tangible benefit. However, the true motivation for proactive medical device trend analysis lies in its power to...
How To Improve Your Google Workspace Security
At SPK and Associates, we are dedicated cybersecurity partners for small and medium businesses (SMBs) worldwide, understanding their unique challenges. Google Workspace, a cloud-based suite by Google, is invaluable for SMBs due to its cost-effective subscriptions,...
The Trio of Documentation: DHF, DMR, and DHR in Medical Device Manufacturing
The FDA plays a pivotal role, setting the gold standard for regulatory oversight. Manufacturers must meticulously adhere to FDA regulations, such as the Quality System Regulation (QSR) under 21 CFR Part 820, governing key aspects like design controls, production...
SBOM Compliance: Navigating the Regulatory Landscape
Recent events, such as the Log4Shell / Log4J vulnerability, underscore the importance of best practices for cybersecurity in software development. And, with increasing cyber attacks, it’s more important than ever that organizations can pre-empt and respond to emerging...
Data Residency for Atlassian Cloud Products
Data residency gives you control over where your in-scope product data for Jira Software, Jira Service Management, and Confluence is hosted. It allows you to choose whether it’s globally distributed or held in place in a defined geographic location. For example,...
Medical Device Trends For 2024
2020 was a wild ride, especially for the medical device world. The pandemic shook things up, making everyone scramble to adjust to a new way of doing things. Now, four years later as we peek into 2024, the medical device scene is still changing. This blog post will...
Unleash the Power of Data in Jira with Custom Charts and Graphs
When it comes to project management and collaboration, understanding your data is key to making informed decisions. Jira is a fantastic option for project managers to keep on track. And, it becomes even more potent with the integration of the Custom Charts plugin by...
Enabling a Whole New Way to Work with MS365
Digital dexterity refers to both the ambition and ability of individuals within an organization to effectively leverage technology for improved business outcomes. Additionally, it goes beyond mere technical proficiency. Instead, it encompasses the enthusiasm and...
A-Z Cuts Time In Tool and Mold Construction Using PTC Creo
For over 75 years A-Z has been a leading supplier of high quality merchandise and service to the global tire industry. In its German 15,000 m² production facility A-Z designs, manufactures and produces tire molds and containers as per customer specification....
Simulation 101 for Non-CAE Experts
Simulation is a powerful tool for predicting and optimizing the behavior of engineering systems, contributing to more efficient and cost-effective product development. And, the primary advantage of simulation in Computer Aided Engineering (CAE) is that it allows...
Latest White Papers
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...
