Resources to Help Accelerate Your Product Development
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Medical Device Compliance: Deciphering the Variances Between MDD and MDR
Back in 1993, the concept of IoT, fitness tracking apps or computerized surgical equipment sounded like something of Star Trek. But in 2023, tech is everywhere - and our medical devices have evolved for the better due to this. However, with evolution, also comes the...
Microsoft Teams: Delivering seamless collaboration, cost savings, and expert support
Losing business time in transit? Supporting a dispersed workforce? Perhaps your tools just don’t stack up to support collaboration full stop. People make teams, but teams need the right tools to work and collaborate effectively. Without them, your business may be...
DevOps as a Service Supercharges Development Pipelines
It seems like just about every company is now a part-time or full-time software company. But, for small and mid sized companies, employing effective practices, such as DevOps to manage the day-to-day, might not be feasible. However, there is a solution. It’s called...
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...
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...
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...
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,...
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....
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