Background

PediaVision, the inventor of an objective pediatric vision screener, was in need of a quality system surrounding their medical device. The early-stage company had a business plan in place, a solid IP platform and a distribution plan, but they needed a quality system, regulatory pathway and quality strategy.

Solution

Regulatory Compliance Associates^® (RCA) provided PediaVision with an overview of the RA and QA requirements and helped PediaVision develop a compliant quality management system. As the company transitioned to manufacturing stage, RCA helped PediaVision implement a CAPA program, a management review process and an internal audit plan.

RCA’s Compliance Assurance Assessment process included:

• Current Good Manufacturing Practice (cGMP)
• International Organization for Standardization (ISO)
• Quality Infrastructure
• Corrective and preventive Action (CAPA)
• Validation
• Facility and Maintenance
• Pre-Approval Inspection (PAI)
• Data Integrity
• Start-up Assessments

 

To begin the Regulatory Compliance Associates^® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.