DOCU Whitepapers

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Qmed Directory Latest Whitepapers.
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Case Study: Full Product Line, Tight Timeline

Fri, 17/11/2017 - 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
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Case Study: Responsiveness/Speed to Market/Prototype To High-Volume Production

Fri, 17/11/2017 - 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
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Case Study: Value Engineering/ Lead-Time Reduction

Fri, 17/11/2017 - 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

Fri, 17/11/2017 - 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.
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Case Study: Process Improvement/Cost Reduction/Speed to Market

Fri, 17/11/2017 - 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.
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Adhesives for Gentle Removal from Skin

Fri, 17/11/2017 - 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

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Leverage the Best Printing Method for Your Project

Thu, 16/11/2017 - 3:01am
Highlighting the Pros and Cons of the most popular 3D Printing Technologies
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Incorporating Steerability into your Catheter

Wed, 15/11/2017 - 3:01am

Key considerations for design and development

As medical technology continues to advance, physicians who specialize in minimally invasive procedures also have advancing expectations — for better performance and improved functionality in the catheters and delivery systems they use. One of the most

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In-Mold Labeling/Decorating for Medical Device

Sun, 12/11/2017 - 3:01am
Providing recognizable branding, instructions, and/or user interface features on a medical device can be a significant challenge; when coupled with ensuring the solution does not create cleaning concerns and will not wear, that obstacle to success becomes even greater.
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Correspondence Between ISO 13485:2016 and 21 CFR Part 820 QMS Requirements

Sun, 12/11/2017 - 3:01am
Correspondence Between ISO 13485:2016 and 21 CFR Part 820 QMS Requirements
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To Air or not to Air

Sun, 12/11/2017 - 3:01am
Many users of foot and hand controls are probably not aware of the bellows version of both these product lines. Traditionally a hand control or footswitch has always had some type of electronic switches encased within its body. The beauty of the bellows model is there are no electronics inside the casings of
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Successfully Incorporating Risk in ISO 9001:2015

Sun, 12/11/2017 - 3:01am
The latest ISO revisions present a shift in mindset towards quality as an underlying concept throughout all organizational operations. Leaders are urged to make quality a priority across all aspects of business, not just those directly involved with quality management decisions. With that shift also comes an
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What Causes Wrinkles in Heat-Sealed Pouches?

Sun, 12/11/2017 - 3:01am
Wrinkles in the seal area can cause a package to be rejected. Let's look at somethings that can be done to avoid packaging failures.
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Costly Mistakes To Avoid When Automating Your Quality Management System (QMS)

Sat, 11/11/2017 - 3:01am

What are the the costly mistakes to avoid & essential steps for success when planning and implementing automation within your quality management system (QMS)?

Download this 8 page white paper + companion checklist from AssurX QMS Software to ensure your quality management system is set up fo

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Case Study: Saving 10,500 Personnel Hours After Implementing Quality Management and Regulatory Compliance Platform

Sat, 11/11/2017 - 3:01am
Learn how an international multi-plant life sciences company implemented the AssurX Quality Management and Regulatory Compliance Platform and saved more than 10,500 personnel hours per year.
Bogged down by internal manual processes, the life sciences company needed a solution to streamline Adverse Event/
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Electronic Complaint Handling | Regulatory Reporting Systems Guidelines

Sat, 11/11/2017 - 3:01am

This white paper includes critical information pertaining to electronic complaint handling. Included within this white paper is a matrix detailing critical steps to implement a web-based complaint handling and regulatory reporting system. Outcomes from implementing an electronic complaint handling system i

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FDA Importer Guidance: Principles & Recommendations for Medical Device Manufacturers

Sat, 11/11/2017 - 3:01am

Hazards that may place consumers at risk can arise at any point during a product's life cycle. The FDA Importer Guidance includes recommendations concerning preventive controls firms can implement to mitigate these hazards. If medical device manufacturers are committed to producing safe, quality products t

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FDA Warning Letters: What FDA Inspectors Look For Regarding CAPA Program Citations And Why

Sat, 11/11/2017 - 3:01am
FDA warning letters continue to show a heavy inspector focus on getting corrective and preventive action (CAPA) right. Recently, 85% of FDA warning letters had CAPA citations. The trend of inspectors using CAPA as a bellwether for the strength of a company's overall operations and compliance is clear. This
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FDA 21 CFR Part 820 Quality System Regulation | Critical Compliance Measures

Sat, 11/11/2017 - 3:01am

This white paper explores FDA's 21 CFR Part 820 Quality System Regulation (QSR). A key component entails that management with executive responsibility shall ensure that the quality policy is understood,

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How to Respond to an FDA Warning Letter Or 483 Observation

Sat, 11/11/2017 - 3:01am
Odds of receiving an Inspectional Observation (483) or a subsequent FDA Warning Letter are sharply on the rise. This white paper addresses what is a 483, how is a 483 different from a FDA Warning Letter, and how you should and should not respond to a 483 or FDA Warning Letter. Also included within the white
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