Regulated Equipment

Companies in the regulated equipment industry face the complex and expensive task of managing compliance and quality assurance in accordance with FDA & GxP regulations (21 CFR Part 11, FDA QSR (21 CFR Part 820) and ISO 13485 specifications). The requirement for documented quality assurance dictates that throughout the life of a project, thousands of risk analyses, validation plans and reports have to be generated, and their contents updated and tracked on an ongoing basis to ensure that the necessary compliance is taking place.

Large, mid-size and small medical device producers are all under enormous pressure to continually enhance product safety and effectiveness while containing operational costs, having to stay compliant at the same time and document what they do in a format that mirrors the applicable regulations and ensures that quality, regulatory and business needs are met.

The amount of time and manpower spent on complying with the regulatory guidelines is the biggest challenge in achieving and maintaining compliance for medical devices or medical equipment producers.

The information inside each individual compliance document, either they are design input specifications or rules based processes, is related. With Microsoft® Office alone this means controlling all this information across multiple separate documents each time anything changes today.

QAvalid™ enables full control over the information in all of the compliance documents and is fully integrated with Microsoft® Office which guarantees that all documents in any project are always kept compliant and ready for inspection - regardless of how many physically separated documents the regulatory information is distributed across!

How can QAvalid™ help you ?

QAvalid™ will help you save 40% to 60% of the time you normally spend unproductively on manually controlling and updating your compliance information as stand-alone Microsoft® Word documents.

For more information on QAvalid™ for Regulated Equipment, click here to download the brochure. (viewing requires Adobe Reader)