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Semiconductor Executive Buy-In: Share A Map for Your MES Journey

Making a good decision on whether, when, and how to select a modern MES can be contentious. Educating executives and the entire team about the current software landscape and opportunity is a prerequisite. International Rectifier’s story of hiring an external firm while also doing their own research proved to be a good approach.… Learn more →

Camstar Supports The FDA Case for Quality

Camstar had a unique opportunity to participate in an exclusive meeting with the FDA, Medical Device industry executives and industry thought leaders, who came together to have an open and candid conversation about the FDA’s Case for Quality (CFQ) Initiative.… Learn more →

Camstar Musculoskeletal Fact Sheet

Camstar’s Medical Device Suite for Musculoskeletal software enables lean manufacturing and builds quality into the process.

Top Musculoskeletal Device Manufacturers Use Camstar to:

Replace Costly Paper and Manual Processes Quickly See Product Issues in Real Time Eliminate Manufacturing Errors Use…  Learn more →

Camstar Cardio Fact Sheet

Camstar’s Medical Device Suite for Cardiovascular software enables lean manufacturing and builds quality into the process.

Top Cardiovascular Manufacturers Use Camstar to:

Replace Costly Paper and Manual Processes Quickly See Product Issues in Real Time Eliminate Manufacturing Errors Use Timely…  Learn more →

UDI-ready eDHR for Compliance and Fewer Product Issues

Medical Device manufacturers are focusing on labels and submission to the Global Unique Device Identification Database (GUDID). It is also important to know that the regulation requires that the UDI appear in a manufacturer’s device history record (DHR) – for good reason. The purpose of the UDI is to rapidly identify and locate specific units or lots of devices in the supply chain in the event of a product quality issue. To do this you need a UDI-ready electronic Device History Record (eDHR) for full traceability of manufacturing.… Learn more →

FDA: Unique Device Identifier (UDI) Must Be Recorded in the Device History Record

Electronic DHR (eDHR) system ensures compliance and reduces the impact of issues

Charlotte, NC (July 30, 2014) – Medical Device companies (Class 3 manufacturers in particular) are busily readying for the FDA’s UDI rule. Most of the focus has been …  Learn more →