ISO standard 9001:2015 refers to the regulatory requirements companies must abide by when managing the quality of their product(s). The main goals of ISO 9001 are customer satisfaction and product improvement. There are a few main things that must be defined when...
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...
It's good practice to observe the regulations a software solution conforms to before choosing one for your business. In this blog post, we will be exploring the updates Atlassian Cloud has added to its regulatory compliance guidelines in recent years.Atlassian Cloud...
As autonomous technology outpaces regulatory standards, further focus is needed to ensure the safety of self-driving vehicles. SPK and Associates, in collaboration with PTC SOTIF ISO/PAS 21448, brings you an insightful guide - a comprehensive eBook on the Safety of...
In this Vlog, Chris McHale, Co-founder, and CEO of SPK and Associates is joined by Carlos Almeida, Vice President of Engineering. Together, they’re discussing FDA compliance and the recent shifts impacting medical device companies. Topics for discussion include...
ALM tooling, when implemented correctly, can support automotive software engineering, Agile transformation journeys and linking requirements to business strategy, encouraging collaboration. Additionally, it can be helpful for providing an overview of QA and testing...
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...
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...
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...
The journey from concept to market-ready medical device is no easy feat. The regulatory economy, development and legislation is intricate. Understandably, compliance with standards is non-negotiable to ensure the safety and efficacy of medical devices. One such...
In September 2022, the FDA ushered in a groundbreaking transformation in the medical device industry by unveiling a new draft guidance on software validation titled "Computer Software Assurance for Production and Quality System Software." For years, the medical...
The MasterControl Summit 2023 was an event serving as a hub for professionals, experts, and thought leaders in quality management and regulatory compliance. It offers a platform for knowledge sharing, industry trends, innovation and best practices. Additionally it...
