Production and operations managers—make sure your preventative maintenance procedures are up to snuff.
Healthcare Executives Say Supply Chain Effectiveness Is Critical to Compete
Product differentiation is important, but failing to nurture supply chain partnerships is a mistake that companies still make.
Managing Pain Points in the Healthcare Supply Chain
Stringent regulations, increased product protection challenges, economic pressures and contingency management have been identified as the most significant contributors to uncertainty in the healthcare supply chain.
What happens when the contract manufacturer a device establishment selects for manufacturing support runs afoul of FDA?
Executives Offer Prospects for Med-Tech Business Model
In order to compete globally, companies must be proactive in their business plans and anticipate the challenges they may face, concur three med-tech executives.
Top Ten Tips + 1 for Medical Device Outsourcing
Follow these eleven tips when outsourcing to your vendors. They will save you heartache, frustration, and money.
Purchasing Controls and Supplier Management
A high degree of risk identification and management throughout the supply chain is what establishes a company as ‘world class,’ says Steve C de Baca – Senior VP, Global Quality & Regulatory, Beckman Coulter Diagnostics.
Controlling Costs in Medical Device Development
Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.
Compliance to FDA’s requirements for distribution are well-scripted and relatively easy for device manufactures to comprehend. However, it is inevitable that Mr. Murphy will eventually visit a device manufacture, resulting in Dr. D’s favorite six-letter word – RECALL.
Material management is one of the most basic functions needed to successful manufacture finished medical devices. If adequate controls are not maintained over raw materials and appropriate identification and traceability maintained, then there will probably be a FDA Form 483 observation in your organization’s future.
