21 CFR Part 211 for drug manufacturers and 21 CFR Part 820 for medical device manufacturers mandate the execution and documentation of employee training. Meeting these requirements ensures that employees understand how to perform their duties within company and industry guidelines.
IHS offers the “IHS Medical Devices Standards Collections,” an online service that enables subscribers to search, view, and print standards documents. Manufacturers can use the service to meet regulatory compliance and quality assurance initiatives in their design control processes.
In “Roadmap to FDA Laws and Regulations: Medical Devices and Radiation-Emitting Products,” readers are presented the fundamentals of medical device regulation as well as insights into how to keep a product on the market and off Capitol Hill’s radar.
The unexpected breakdown of rotating machinery is the major cause of emergency downtime in industries.
The “2005-2006 Device Inspections Guide” contains FDA’s latest rules, regulations, policies, and procedures for device inspections.
The National Electrical Manufacturers Association (NEMA) has converted its Conformity Assessment Guide to a continually updated online format available to subscribers.
Powerstax’s new website provides technical, commercial, and practical information on AC and DC power conversion products. Additionally, a free copy of the company’s AC-DC short-form catalog can be downloaded. Information: www.powerstaxplc.com.
Readers can go to Universal Air Filter’s website for information on medical equipment air filters. Sections titled “How to Specify an Air Filter” and “Prototype Request” show how to spec air filter prototypes within five working days.
The latest addition to Cincinnati Test Systems’ web-based offerings is an online catalog about seals that are molded using cut-resistant, high-grade polyurethane. The catalog offers advice on finding the proper seals for any application based on seal dimensions, shape, and durometer.
Responding to requests, V-infinity offers on its website the majority of its dc-dc converters—more than 1,500 individual models—in 3D.
To improve the safety and economics of bodily fluid disposal, a medical supply company has developed two portable collection units: the High Fluid Cart and the Safety Station.
These 10-ml glass vials with screw-top caps contain a septum that enables suspensions to be dispensed using either a pipette or a needle and syringe. Spore suspensions are pure suspensions of viable spores from specific organisms of known resistance to various sterilization processes.
TechTeam is a sterilization technical support group that helps revalidate existing sterilization processes, develop new product validations, examine materials for medical devices, and assist with gamma, EtO, and electron beam sterilization needs.
Raven's offerings include steam, dry heat, and EtO dvalue testing according to USP, AAMI, and ISO guidelines. Operating four AAMI/ISO compliant BIER vessels, the company can inoculate a device and perform dvalue analysis.