New AQC Medical Device Workstream

Avoca Quality Consortium

Medical Device Workstream

Access Tools and Collaborate on Future Development

We are pleased to announce the launch of WCG’s Avoca Quality Consortium (AQC) medical device workstream!

Medical device guidance and regulations require manufacturers, or sponsors of device manufacturing, to adhere to rigorous processes to obtain regulatory approval and to maintain the safety and efficacy of products. This new AQC workstream enables collaboration and action needed to advance your clinical research, saving valuable time and resources with expert-developed tools, templates, and guidance.

The first set of leading practices is specific to design controls, which are essential to help ensure that products are safe, effective, and meet regulatory standards before they reach the market.

• Design Control Overview and Requirements
• Design and Development Plan and Template
• User Needs Document and Template
• Design Input Requirements and Traceability Matrix Template
• Design Output Requirements
• Design Verification and Validation
• Design Transfer Requirements and Template
• Design Reviews and Template
• Design History File and Template

–

The AQC’s leading practices for the design and development of medical devices, or combination products that have a device constituent, help to navigate specific medical device regulations, including those from the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Leading practices on risk management and management responsibilities are coming soon.

AQC members can view the new Medical Device Workstream page in the Knowledge Center for more information and links to resources.

Join the AQC now to leverage these critical documents and to be instrumental in shaping the future of the medical device library and workstream!

CONTACT US TO JOIN ››

// ABOUT THE AQC //