Case for Quality
The medical device and diagnostics industry holds a crucial role in the prevention, monitoring, and treatment of diseases, and in the improvement of the quality of life for people with various ailments and disabilities. As the world’s largest medical technology association, AdvaMed is dedicated to ensuring timely patient access to safe and effective medical products, and to providing physicians, medical technology professionals, and others with the advocacy and tools they need to help create life-changing innovation.
Along with FDA, AdvaMed believes that product quality goes beyond compliance with the current Quality System Regulation (21 C.F.R. Part 820). The Library of Successful Quality Practices stems from this belief and was created by AdvaMed and its members to help medical technology quality professionals.
We want your input. Please send all questions and materials to Steven Silverman.
Benefits of Using the Case for Quality Library
This "Library of Successful Quality Practices" is not technology-specific, nor is it intended to be exhaustive or all-inclusive. However, our aim is to provide several key benefits:
- This Library is a compilation of successful quality practices employed by contributing AdvaMed member companies.
- The Library provides a selection of current industry practices with explanations of their value.
- It is intended for quality professionals to use as a resource, not as a prescriptive guidance/textbook/checklist.
- It can serve as a road map or toolkit for companies seeking to improve their quality systems and/or product quality by leveraging proven industry methods.
- Large and small companies also may benefit from using the library’s catalog of wider ranges of industry practices to enhance their own.
Case for Quality: Design Control CtQs
The first “volume” in AdvaMed’s Library of Successful CtQ Practices is on design control CtQs. Design control CtQs are intended to identify the practices, processes, and cultures required to effectively manage the design and development of new or existing medical devices. It explains how the CtQs fit into a product’s lifecycle and how they align with 21 C.F.R. Part 820, Essential Design Requirements, and FDA’s QSIT Inspectional Guidance.
There are 11 presentations included in one PDF document that illustrate the successful practices currently used by AdvaMed member companies, along with appendices that provide more detail on specific aspects of design control (such as obtaining “voice of the customer” requirements and translating these requirements into CtQs).
Case for Quality: Supplier Quality & Purchasing Controls
The second volume in the Case for Quality library is a compilation of individual presentations from 10 AdvaMed member companies on their successful supplier quality and purchasing controls practices.
Case for Quality: Quality Culture Playbook
The most recent volume in AdvaMed’s Library of Successful Quality practices is a Quality Culture Playbook. This resource is directed to device manufacturers that want to create, improve, and sustain their organizations’ quality culture. Takeaways from the playbook include what quality culture is and why it matters; the behaviors that drive quality culture; the workstreams to operationalize quality culture behavior; and strategies to deploy a quality culture initiative.
Case for Quality: Risk Management
The purpose of a risk management program or system is to establish a process to identify, evaluate and reduce risk.
We have gathered several examples from member companies who have established successful risk management practices.