When choosing a Product Lifecycle Management (PLM) software, it is important to thoroughly compare the solutions on the market. You have likely heard great things about the two we will be covering today. To aid in your decision, we will detail the unique features and...
Edwin Chung
Optimizing Document Control Processes: A Deep Dive into ISO 9001:2015 and Good Industry Practices
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...
ISO 9001: Quality Management in Medical Device Manufacturing
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...
Exploring the Differences between PTC Windchill PLM and Oracle Agile PLM
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...
Comparing PTC Windchill PLM vs SAP PLM
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...
Top Takeaways from SolidWorks 3DEXPERIENCE World 2024
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...
Frequently Asked Questions for PTC Creo+
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...
Design Controls Best Practices for Medical Device Companies
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....
MasterControl’s Quality Management Software: Navigating Compliance with Confidence
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...
How PTC Windchill Transformed Volvo Trucks’ Product Lifecycle
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...
Medical Device Compliance: Deciphering the Variances Between MDD and MDR
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 Trio of Documentation: DHF, DMR, and DHR in Medical Device Manufacturing
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...