With information curated and collated by experts within the medical device and medtech manufacturing industry, Flexan publications represent a comprehensive collection of the most relevant news and information in the medical device industry as it relates to device and component manufacturing.
Advanced Micro-Catheter Design Improves Patient Experience
Recognizing an increasing concern of vascular injury, infection and misplacement, a global medical device company chose to partner with Flexan, LLC to design an advanced micro-catheter.
The FDA can’t physically be at every medical device manufacturing facility every day to ensure the safety and reliability of products. What it can do is enforce a system of continuous self-improvement at each facility — known as Corrective And Preventive Action (CAPA). When OEMs choose an outsourcing partner, they need to trust the effectiveness of the supplier’s CAPA program, and they need to trust that the supplier’s culture sustains quality each and every day, for every device.
How to Recognize Effective CAPAs & A Culture of Quality
Are You Gambling with Medical Device Compliance?
8 Reasons To Ditch Paper Device History Records
What is the probability thousands of handwritten records created by production employees are error free? That’s the gamble OEMs make when they accept handwritten device history records (DHRs) from their contract manufacturing organizations (CMOs).
One medical device manufacturer found up to 20 percent of all in-process DHR packets contained an error(1). Such errors can lead to consequences such as FDA warning letters or even a shutdown. According to www.malcombatchrecords.com, 84 percent of warning letters issued by the FDA had observations for inadequate or missing documentation.
I think we both know the answer to that question.
With price competition and cost pressures squeezing the profitability of medical devices, supplier networks are the latest target for cost reductions — and rightfully so. Complex supplier networks add costs, without adding value.
OEMs: Discover The Hidden Costs And Risks In Your Complex Supplier Network
Are your customers willing to pay for the cost of complexity in your supplier network?
The Use Of Implantable Silicone In Medical Devices
The uses for silicone rubber molding in short-term and long term medical devices have continued to grow over the past few decades. This material is biocompatible, making it ideal for implantable devices with critical functions such as defibrillators, heart pumps, and surgical reconstructive components. In order to put this material to its optimal uses, medical device manufacturers need to understand how silicone is handled, processed, and molded into parts.
This e-book covers the characteristics and science behind implantable silicone, as well as its uses and processes, and the importance of patient safety. Download the full book for more in-depth information.