FDA Expectations for Traceability in Device & Diagnostic Design - Watch the video.
Free Webinar Dec 15th -“FDA's Reprocessing Guidelines: Impact to Cleaning and Sterilization Studies ”
Enercon Industries is offering a free surface treatment comparison chart that includes embedded video of atmospheric plasma and flame technology . Blow-ion, blown arc & variable chemistry plasmas are used to increase clean, etch and functionalize surfaces to improve adhesion and surface energy. Each treatment technology offers unique benefits and this chart breaks down the advantages and application considerations of each technology.
Medical device manufactures are constantly pushing the boundary of innovation and delivering more powerful products. The rapid pace of growth also requires robust systems to ensure regulatory obligations and reporting requirements are being met. A robust QMS will offer a comprehensive suite of quality and compliance management solutions that serves the unique needs of medical device manufacturers. They enable companies to take a risk-based approach to quality and compliance ma...
Dymax Corporation, a world-class manufacturer of innovative adhesive, coating, dispensing, and light-curing systems for high-performance medical device applications, was approached by Medical Excellence of Madison, Inc., for help with a challenging application. MEM, a value-added contract medical device manufacturer of high quality, sterile, disposable Class I and Class II medical devices, was presented the challenge of designing a new low-cost, disposable Laryngeal Mask. The original device...
This webinar will examine some of the challenges of using a manual and fragmented system for managing Adverse Event Reporting, including: ■ Fragmented, disconnected processes, IT systems and approach -- Product complaints separate from Adverse Event systems and from Investigation/CAPA systems -- Separate websites to access for coding adverse events (for e.g. – MSSO for MedDRA) ■ Insufficient closed-loop processes result in FDA warnings and co...
Fluid + Power All-In-One Connector The Hybrid Connector from Colder Products Company eliminates the need for multiple connections and simplifies the user interface between remote tools and a device. Medical professionals can quickly change or replace modular tools, umbilicals or hand pieces that require power, signal, air or fluids in a wide range of medical device applications. View Hybrid Connector movie. Read more information on the hybrid technology.