The dossier reflects the manufacturer’s commitment to quality, safety, and transparency, helping to establish trust with regulators, healthcare providers, and patients alike.
Month: January 2025
How to Manage Regulatory and Quality Risks in Medical Device Projects
Let’s outline strategies for managing regulatory and quality risks to ensure project success and compliance.
Handling Non-Conformances: Root Cause Analysis and Corrective Actions in Quality Assurance
In the world of quality assurance (QA), non-conformances can be a company’s Achilles’ heel or an opportunity for significant improvement. Whether in manufacturing, healthcare, software development, or other industries, identifying and addressing non-conformances is essential to maintaining high standards and building trust with stakeholders. Patrick Gora of Rochester understands that at the heart of effective… Continue reading Handling Non-Conformances: Root Cause Analysis and Corrective Actions in Quality Assurance
The Role of FDA Pre-Submission Meetings in Successful Regulatory Approvals
Navigating the regulatory landscape of the Food and Drug Administration (FDA) is a critical step in bringing medical devices, pharmaceuticals, or biologics to market. The process can be daunting, requiring rigorous documentation, adherence to strict guidelines, and often, significant financial investment. Amid these challenges, the FDA’s pre-submission meetings stand out as a valuable resource for… Continue reading The Role of FDA Pre-Submission Meetings in Successful Regulatory Approvals