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...
When choosing a Product Lifecycle Management (PLM) software, it is important to explore options to conjecture which suits your business needs. Our industry experts understand this can be time-consuming. This is why we have gathered information, to save you time in...
There are many options on the market, each with their own pros and cons. But, choosing a Product Lifecycle Management (PLM) software doesn’t have to be overwhelming. As industry experts supporting businesses globally, we’re going to be comparing PTC Windchill vs SAP...
The 3DExperience (3DX) World 2024 displayed the convergence of innovative technologies and creative ideas in design and engineering. Hosted by Dassault Systèmes, it is an epicenter for SolidWorks users, third-party app suppliers, gold partners, and major workstation...
As trusted PTC partners and experts, we understand the importance of staying ahead in the world of CAD technology. In this blog post, we'll address frequently asked questions about PTC’s SaaS CAD too, Creo+, providing insights into the revolutionary and the powerful...
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....
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...
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...
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...
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...