Qmed Directory Latest Whitepapers.
Updated: 53 min 38 sec 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
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.
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.
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.
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
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 The truth is, it's outdated thinking.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
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
Enhance Product Lifecycle and Profits with a Proactive Approach
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.
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
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
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
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.
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
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
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/
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