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...
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...
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...
The FDA compliance standards bring nuanced compliance considerations to your sector, don’t they? In pharmaceuticals or biotech, system reliability is essential. And, central to that is Computer System Validation (CSV). Essentially, it demonstrates a commitment to...
We're thrilled to share that all-new SolidWorks Desktop CAD licenses will now encompass "Cloud services" as part of your subscription. Moreover, for our existing SolidWorks users, a seamless avenue will open up to integrate these secure cloud capabilities. You might...
SolidWorks PDM (SWPDM) is a powerful software used extensively in the engineering and design industries. However, like any program you currently use, it may occasionally experience performance issues that hinder your productivity. In this blog post, we'll explore the...
Wondering if you can deliver a SolidWorks PDM and MasterControl integration? Our experts did it. Discover how, and the benefits, in this video with Michael Roberts, Vice President at SPK and Associates, and Ed Chung, Director of Engineering. SolidWorks PDM and...
Struggling with communication and process fragmentation issues in your engineering operations? PTC Windchill was seen as the best Product Lifecycle Management tool in these success stories. It helped two engineering companies achieve improved productivity and reduced...
3DX - 3DEXPERIENCE World 2023 is the biggest gathering of its kind. Hosted annually by Dassault Systèmes. And, this event brings together the brightest minds from the aerospace, automotive, and industrial equipment industries to share their knowledge and expertise....
