While compliance with MDR is demanding, it ultimately benefits patients by ensuring that medical devices meet the highest safety and performance standards.
Blog
How AI is Changing the Future of Pharmacovigilance: Regulatory Implications
We explore the impact of AI on pharmacovigilance, the benefits it offers, and the regulatory implications that accompany its adoption.
The Role of Companion Diagnostics in Precision Medicine: Regulatory Challenges and Market Trends
CDx development and approval face significant regulatory hurdles, and the market dynamics for these diagnostics continue to evolve.
Essential Components of a Strong Regulatory Dossier for Medical Devices
The dossier reflects the manufacturer’s commitment to quality, safety, and transparency, helping to establish trust with regulators, healthcare providers, and patients alike.
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
The Evolving Role of Real-World Evidence (RWE) in Regulatory Submissions for Medical Devices
In this blog, we discuss how Real-World Evidence is reshaping the regulatory landscape for medical devices.
Common Reasons for Delays in Regulatory Submissions and How to Overcome Them
Understanding the common reasons for delays and adopting strategies to mitigate them can help organizations streamline their processes and achieve timely approvals.
Understanding Combination Products: Regulatory Requirements for Devices with Drug or Biologic Components
A comprehensive overview of combination products, their regulatory requirements, and the pathways to navigate these challenges.