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...
The FDA's heightened cybersecurity standards, implemented in October 2023, have changed submission requirements for medical devices. In this blog post, we'll explore the key updates and detail key information about effective Bill of Materials (BOM) management,...
Ensuring regulatory compliance and fostering trust in products are paramount for medical device manufacturers. The FDA, European Competent Authority, and Health Canada closely oversee design, development, and manufacturing for patient safety and efficacy....
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...
Looking for a great out-of-the-box solution for a Quality Management Systems (QMS) that exceeds the compliance requirements for FDA? MasterControl could be a good option for you. It even includes the stringent guidelines outlined in 21 CFR Part 820. Let’s take a...
There is a paramount importance to staying ahead of new risks. After all, more and more crop up each day as technology and processes change. So, in this blog post we’re exploring the 2024 trends for risk management.Why Manage Risk? It sounds like a simple question...
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...
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...
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...
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...
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...
Today, we're covering an important discussion led by our Vice President of Sales and Marketing, Michael Roberts to discuss the intersection of FDA regulations and medical device cybersecurity. You can watch the video to get insights in to the full discussion, or check...
