Qmed Directory Latest Whitepapers.
Updated: 1 hour 47 min ago
Performing a cleaning validation during the initial phase of a device's lifecycle aids manufacturers in complying with current good manufacturing practices (CGMP) and quality system (QS) regulation as set forth by FDA for medical device manufacturers. The data gathered during cleaning validations helps manufa
Validating cleaning instructions for a tray of reusable orthopedic devices is an important milestone on the path to obtaining FDA clearance for those devices. Although the process of validation can seem daunting at first, medical device manufacturers seeking to successfully navigate this process can do so
The Significant Benefits of Premarket & Postmarket Particulate Testing of Cardiovascular Devices
Download this whitepaper to learn about the various biocompatibility and sterilization considerations surrounding 3D-printed orthopedic devices. 3D-printed orthopedic medical devices are gaining attention and popularity due to their potential for enhanced biocompatibility, customizability, and cost-effectiven
Download this whitepaper to examine the various ways in which chemical characterization can augment and refine the biocompatibility testing process.
Using analytical chemistry and data from the compound libraries to assess the finished device can yield more specific data about these extractable com
Volume 1: A Rapid Injection Molding Reference Guide for Product Designers and Engineers
How Rapid Manufacturing can Increase Speed to Market for Devices and Components
Industrial 3D printing opens up many new design possibilities, but it's important to keep a few fundamental principles in mind when designing for additive manufacturing processes. Most of these are fairly obvious like feature resolution, surface finish, and material selection, but there's more to 3D printing
The challenge for any outsourcing decision making team is to
develop an outsourcing strategy that keeps costs within budget over the life of
the product. The reason this can be difficult is because landed cost and total
cost of ownership are typically different numbers. Often the country with the
The use of three-dimensional (3D) printing techniques to address challenging fabrication problems has become mainstream over the past decade. While this rich resource has extended fabrication of personalized medical devices to the limit of our imagination, the myriad materials and morphologies available pr
Reusing single-use devices that have been safely reprocessed by a third-party reprocessor can enable healthcare providers to maintain high-quality patient care while saving on costs and reducing medical waste. Validated functionality testing must be paired with validated cleaning, disinfection, and steriliza
Manufacturers have many definitions for how long you can use Pressure Sensitive Adhesive (PSA). These definitions are dependent on the manufacturer; there are no industry standards. First, we will look at the definitions and science behind PSAs and then define use, life and expiration.
Selecting a contract manufacturer for your medical device can be a daunting task. Your decision of who you use, what services they provide and changes they make can have either positive or negative long term implications for your company.
Many users of foot controls are probably not aware of the bellows version of this product line. Traditionally, a footswitch has always had some type of electronic switches encased in its body with an electric cord to connect to the user's equipment. A challenge of an electric footswitch is that you have elect
Stopcocks have been used for decades to deliver infusion therapy in patients of all ages and in all health care settings. During the past 20 years, a growing number of studies have validated concern about the risk of the open lumen allowing intraluminal contamination. Additional studies highlight fluid flow d
A selection of medical/skin adhesives were coated onto substrates and physical properties (Shear, Adhesion to Release, 180° Peel and MVTR) tested before and after exposure to e-beam sterilization of 27 and 40 kGy. Of the four adhesives tested, two displayed a much lower effect from e-beam exposure than the ot
Mergers and acquisitions (M&As) continued to change the landscape in the medical device and diagnostics industry in 2017. See which companies were bought, sold, or spun-off last year with our comprehensive list of 2017 medtech M&As. Information in the report includes the following:
Established data-based evidence about Klaran's performance for disinfection determined by Pathogen testing on various microbes.