This white paper discusses six characteristics that combine to form a
Cardiovascular Device Manufacturer: Moving From Paper Processes to an Automated Enterprise Quality and Compliance System | Case Study
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
Case Study: Saving 10,500 Personnel Hours After Implementing Quality Management and Regulatory Compliance Platform
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
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
This white paper provides an in-depth look at the growing paradigm shift from relying on overburdened in-house IT departments and moving toward leveraging a nimble OnDemand Cloud QMS solution. As part of a heavily regulated industry, medical device m
Getting computer system validation (CSV) right is a key to complying with important regulations and running the most efficient shop possible in the medical device industry.
This white paper outlines a proven approach to achieving a compliant, well-controlled, validated, and easily maintained system.<
When designing a medical foot control there are many things that must be into account. Certain criteria must be followed in order to produce an interface that meets the standards set forth by the Medical world. Deciding on things such as paint type and the weight of the foot switch may seem minor, but they