The burden on quality and operations leaders to introduce compliant and innovative medical devices to market is great. And as regulatory standards, market requirements, and device complexities have evolved, so too has the weight of the burdens these leaders face. Read how product-centric QMS enables … [Read more...]

RefleXion Medical is shaping the future of cancer treatment while adhering to the highest quality and compliance standards. They needed a single product realization solution to address quality and design controls while enabling regulatory compliance. Read how RefleXion met this challenge while … [Read more...]

Medical device manufacturers and their supply chains must get their products to market quickly while facing new technological challenges, global competition, and a myriad of risks. Learn how you can better compete with ever-changing regulations to deliver high-quality products to … [Read more...]

Medical device manufacturers must establish quality systems to comply with FDA regulations and other standards like ISO 13485. A single, unified quality management system (QMS) to manage documents, SOPs, training records, quality, and product releases increases traceability between all impacted … [Read more...]

Often small to medium-sized businesses make do with the tools they have to manage their product data. Paper, spreadsheets and email are often used throughout the product development and engineering change management processes. These tools can wreak havoc when product information is released into … [Read more...]

What solution helped a lighting manufacturer reduce engineering change order (ECO) cycle times by 75%, a networking company improve ECO cycle times by 70%, and a digital processing business accelerate time to market by 20%? The answer? Product lifecycle Management (PLM) software. The financial … [Read more...]

In the world of product design and manufacturing, the bill of materials (BOM) is a critical product information record for both the engineering and manufacturing teams. Managing BOMs with the wrong tools can cause product errors, delays and compliance failures. In this whitepaper, we outline the … [Read more...]

Manufacturers of complicated electronic products must manage, track and store hundreds — if not thousands — of parts in their product development processes. And every time a new part is added to a company's library, it can cost $15k in time and effort to qualify and rollout. That's serious money. … [Read more...]

This white paper provides an overview of manufacturing tools like mechanical computer aided design (MCAD), product data management (PDM), electronic design automation (EDA) and enterprise resource planning (ERP) and describes how to bridge the gap between engineering and manufacturing. … [Read more...]

Smart companies know that well disciplined new product introduction (NPI) processes are critical to success. Yet, even these companies can suffer from NPI failure when important projects, policies, and guidelines are haphazardly managed as clumsy manual processes. For a guide to the best practices … [Read more...]