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Developing a Quality System on a Managed Budget
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 regulatory and quality pathway.
We would absolutely recommend RCA to set up and manage a quality system. We couldn’t afford to hire personnel with RCA’s expertise and our engagement allows us to tap into their experts as needed while we focus on growing the company.
Solution
Regulatory Compliance Associates® Inc. (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
Results
RCA worked alongside the organization, providing management oversight and backfilling their gaps while working within a fixed monthly fee. This enabled PediaVision to scale the company on a managed budget while meeting quality and regulatory standards.
About RCA
Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Regional offices in Florida, Colorado and Europe
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
