DOCU Whitepapers

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Qmed Directory Latest Whitepapers.
Updated: 21 min 43 sec ago

Wireless

Wed, 17/01/2018 - 3:01am
Customers using medical equipment are increasingly moving towards wireless options for communication rather than traditional cable connections.
Categories: DOCU Whitepapers

Establishing Bioburden Alert and Action Levels

Wed, 17/01/2018 - 3:01am

Most national and international standards regarding bioburden, sterilization, or environmental testing refer to establishing alert and action levels to assist in demonstrating continued control over a process or product. The standards sometime include guidance on evaluating the data but seldom go any furth

Categories: DOCU Whitepapers

6 Critical Elements of a Modern Change Management System

Wed, 17/01/2018 - 3:01am
Change control process automation creates a consistent system to manage change requests. FDA regulated industries are held to regulatory guidance that reinforces the necessity of implementing an effective change management system.
This white paper discusses six characteristics that combine to form a
Categories: DOCU Whitepapers

Collagen for Cell Delivery

Tue, 16/01/2018 - 3:01am
Advances in regenerative medicine have opened doors to new possibilities in patient treatment with the potential to repair or replace damaged tissue using cell delivery. A critical aspect of cell delivery is the delivery vehicle.
Categories: DOCU Whitepapers

Justification for Use of Bovine Animal Tissues in the Medical Device

Tue, 16/01/2018 - 3:01am
The advantages of using bovine tendons as opposed to a synthetic material or tendons originating from other non-ruminant animal species (e.g. porcine tissues in the manufacture of collagen for use in a medical device.
Categories: DOCU Whitepapers

CARE MOTION

Fri, 12/01/2018 - 3:01am
TiMOTION guarantees complete customer satisfaction by providing a competitive packaged actuator solution coupled with a wide range of high quality products, global service networks and “on demand” R&D resources.
Categories: DOCU Whitepapers

Paradigm Shift in PreOperative Skin Preparation

Thu, 11/01/2018 - 3:01am
Surgical site infections (SSIs) are the number one most costly hospital acquired infection (HAI), and the second most common. 1, 2, 3 They can lead to the prolonged patient suffering, extended hospitalizations, and cost the healthcare industry billions of dollars, much of which is no longer reimbur
Categories: DOCU Whitepapers

Finding Balanced Solutions for Medical-Grade Materials

Tue, 09/01/2018 - 3:01am
When medical device and diagnostics manufacturers work through material selection for their products, polymers such as polycarbonate (PC), polyethylene terephthalate (PET), and poly-vinyl chloride (PVC) are commonly used materials that first come to mind. Some of these established grades are used because they
Categories: DOCU Whitepapers

The Current Regulatory Landscape for EO Residue Levels in Medical Devices: What Manufacturers Need To Know Now, and What May Be on the Horizon

Thu, 21/12/2017 - 3:01am

Download this whitepaper to learn the latest updates on European regulations and guidelines for residual ethylene oxide in medical devices.

Ethylene-oxide (EO) gas sterilization remains one of the most efficient and effective ways of deactivating bacteria and other potentially dangerous living mi

Categories: DOCU Whitepapers

FDA Compliance Bulletin: FDA 21 CFR Part 11 Electronic Records | AssurX

Mon, 18/12/2017 - 3:01am
This FDA compliance bulletin describes the designed, intended compliance of AssurX QMS Software with FDA 21 CFR Part 11 Electronic Records: Electronic Signatures from the software functionality and integration aspect.
Categories: DOCU Whitepapers

Can Use of Sequential Injection Molding Reduce Production Costs on Your Project?

Thu, 14/12/2017 - 3:01am
Tooling design can be critical to achieving commercialization goals. Tool design has a direct impact on product cosmetics, cost and scalability. Sequential injection molding offers both cosmetic and throughput benefits, but in its traditional form has required a bulky mold and use of larger tonnage machin
Categories: DOCU Whitepapers

Cardiovascular Device Manufacturer: Moving From Paper Processes to an Automated Enterprise Quality and Compliance System | Case Study

Wed, 13/12/2017 - 3:01am
A Class III medical device manufacturer was facing quality challenges related to growth and siloed, manual processes that, if not streamlined, could ultimately be an issue of life or death.  AssurX Quality and Compliance Management Software enabled
Categories: DOCU Whitepapers

Adhesives for Gentle Removal from Skin

Thu, 07/12/2017 - 3:01am

A novel medical pressure sensitive adhesive (PSA) and tape has been developed to reduce pain upon removal from variety of skin types. The new technology provides a solution to medical device manufacturers who require PSA tape to hold the medical device securely in place, while being able to remove it gentl

Categories: DOCU Whitepapers

The Design for Manufacturing Approach

Wed, 06/12/2017 - 3:01am
Are you taking the steps to avoid manufacturing efficiencies? Read our white paper to learn how a Design for Manufacturing approach with a contract manufacturer can help you mitigate risks while streamlining your manufacturing processes.
Categories: DOCU Whitepapers

Fact or Fiction: Debunking the 1 lb. standard for seal strength testing…

Wed, 29/11/2017 - 3:01am
  • Challenges in the early 90's with 1.0 lb. minimum for pouches
  • “How do you validate to a 1.0 lb. minimum using 90° unsupported peel test method for uncoated pouches?”
  • The answers were that you can't, unless you use the 180° supported test method.
  • Over 25 years, people are
Categories: DOCU Whitepapers

Case Study: Full Product Line, Tight Timeline

Sun, 26/11/2017 - 3:01am
Developing a new medical device, especially a long-term implant, is never easy. But bringing an entire metal implant line of over a hundred parts to market raises the difficulty factor to a whole new level. That was the challenge a growing medical device company brought to Donatelle, along with the requiremen
Categories: DOCU Whitepapers

Case Study: Responsiveness/Speed to Market/Prototype To High-Volume Production

Sun, 26/11/2017 - 3:01am
Challenge: The customer needed a proof-of-concept and validation parts on a newly designed component, a barbed pusher body, for their vascular-closure device. The part was less than .170” in length with a maximum diameter of Ø.083” stepping down to Ø.042” where the barbs are located, and had a Ø.021” center t
Categories: DOCU Whitepapers

Case Study: Value Engineering/ Lead-Time Reduction

Sun, 26/11/2017 - 3:01am
Challenge: Autocam Medical independently proposed changes in an existing drill design for an OEM in order to deliver cost savings without sacrificing performance.
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Case Study: Responsiveness/Design of Manufacturability/Speed to Market

Sun, 26/11/2017 - 3:01am
Challenge: A major Medical Orthopedic OEM requested a soft launch of 50 kits, including Implants: Plates, Screws, Buttons, Hooks and Instruments: Drivers, Drills, Depth Gauges and Guides – four months earlier than anticipated.
Categories: DOCU Whitepapers

Case Study: Process Improvement/Cost Reduction/Speed to Market

Sun, 26/11/2017 - 3:01am
Challenge: Independently develop and share value-added process solutions with an established customer in order to obtain a better price position by improving the value stream.
Categories: DOCU Whitepapers