DOCU Whitepapers

Subscribe to DOCU Whitepapers feed
Qmed Directory Latest Whitepapers.
Updated: 53 min 38 sec ago

7 Principles of Product-Centric Quality Management

19 hours 52 min ago
Having a rock-solid approach to quality is a prerequisite for medical device success. The burden on quality and operations leaders to introduce compliant and innovative medical devices to market is great. And as regulatory standards, market requirements, and device complexities have evolved, so too has the we
Categories: DOCU Whitepapers

Case Study - Advanced Energy Device Engineered with Ultra-Precise Tubing Tolerances for Superior Performance

Tue, 13/11/2018 - 3:01am
Viant facilitated the design and managed the production of the inner and outer tube. Viant's deep engineering and process expertise drove development to optimize critical areas of the tube to reach the extreme tolerances needed to achieve the desired performance.
Categories: DOCU Whitepapers

Case Study - Reverse Engineering & Manufacturing Transfer Result in Cost Savings, Reduced Risk, and Increased Security

Tue, 13/11/2018 - 3:01am
The Viant team leveraged its product design experience to reverse engineer 35 components, using in-house inspection as well as laser and CT scanning to get accurate 3D geometry.
Categories: DOCU Whitepapers

Can it be - The Medical Industry is Operating in Compliance?

Mon, 12/11/2018 - 3:01am
In our last FDA Update, we implied that FDA policy can change on a “dime” and that policy is basically controlled by Congress. As result of the November 6 National Election results, there is a major shift in the control of Congress.
Categories: DOCU Whitepapers

Product Centric QMS: A Critical Advantage for Regulated Companies

Tue, 06/11/2018 - 3:01am
Medical device manufacturers must establish quality systems to comply with FDA regulations and other standards like ISO 13485. A single, unified quality management system (QMS) to manage documents, SOPs, training records, and quality processes in context with the entire product record increases visibility and
Categories: DOCU Whitepapers

Design and scale shaped liquid tight bags without the risks.

Tue, 06/11/2018 - 3:01am
Who says a soft, flexible, liquid tight medical bag with shapes and fitments must be made of PVC? Actually, many packaging experts out there today will tell you that. The truth is, it's outdated thinking. With the right handling capabilities and expertise, polyolefins can deliver all the performance
Categories: DOCU Whitepapers

Read how an OEM customer achieved significant noise reduction using our proprietary optiSLITE ball screws.

Sat, 03/11/2018 - 4:01am
An established maker of multi-axis stages was seeking smooth, quiet, long-lasting performance from its linear motion technology. The company's engineers decided to perform a comprehensive test on identical stages between a regular ball screw from a large OEM and new optiSLITE ball screws
Categories: DOCU Whitepapers

Consultancy vs Contract Designer

Sat, 27/10/2018 - 3:01am
Categories: DOCU Whitepapers

Demand More From Suppliers

Sat, 27/10/2018 - 3:01am
Categories: DOCU Whitepapers

Smarter Design for a Longer Life

Sat, 27/10/2018 - 3:01am
Enhance Product Lifecycle and Profits with a Proactive Approach
Categories: DOCU Whitepapers

The Design for Manufacturing Approach

Sat, 27/10/2018 - 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

EO Residue Levels in Medical Devices

Wed, 24/10/2018 - 3:01am
Sterilizing medical devices via ethylene oxide gas is an effective and common practice within the industry. EO gas is active at a relatively low temperature compared to other methods, such as steam, and it is compatible with plastics, polymers, and many products that are not compat¬ible with other sterilizati
Categories: DOCU Whitepapers

System Integrations Available with the AssurX QMS Software Platform

Sun, 14/10/2018 - 3:01am
A common problem facing many businesses is the integration of disparate systems to manage quality processes and regulatory compliance. The advent of Single Sign-On (SSO) applications and technology has allowed us to be able to more easily manage the logins to different systems, but the issue of
Categories: DOCU Whitepapers

6 Critical Elements of a Modern Change Management System

Sun, 14/10/2018 - 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

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

Sun, 14/10/2018 - 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

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

Sun, 14/10/2018 - 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

Costly Mistakes To Avoid When Automating Your Quality Management System (QMS)

Sun, 14/10/2018 - 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

Categories: DOCU Whitepapers

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

Sun, 14/10/2018 - 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/
Categories: DOCU Whitepapers

Electronic Complaint Handling | Regulatory Reporting Systems Guidelines

Sun, 14/10/2018 - 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

Categories: DOCU Whitepapers