Volvo depends on concurrent engineering to manage product complexities. They accelerate industrialization by efficiently sharing design changes between engineering and manufacturing. This is crucial for quick component development and production. For Volvo, PTC...
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...
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...
Considering the leap to cloud-based CAD and PDM solutions? A move to platforms like SolidWorks 3D CAD in the cloud paves the way for unmatched flexibility. Imagine accessing intricate engineering data from anywhere at any time. And, the benefits don’t end there. In...
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...
