PMConsultant

  Developing a compliant medical device risk management plan is one of the most critical regulatory requirements for medical device manufacturers seeking successful 510(k), De Novo, PMA, or SaMD submissions in the USA. The U.S. Food and Drug Administration (FDA) expects companies to demonstrate a proactive approach to identifying, evaluating, controlling, and monitoring risks throughout the product lifecycle—not just during device development. A well-structured risk management plan not only supports compliance but reduces the probability of product recalls, post-market failures, cybersecurity incidents (for SaMD and connected devices), and legal liability. Whether you're a startup developing your first device or an established medical device organization expanding product lines, understanding how to build a compliant risk framework is essential. Understanding the Regulatory Expectations: FDA 21 CFR 820.30 and ISO 14971 Alignment FDA 21 CFR 820.30 (Design Controls) mandates medical...

Post-market surveillance (PMS) is a critical regulatory requirement that ensures the continued safety, performance, and compliance of a medical device after market approval. For manufacturers operating in the United States and the European Union, regulatory expectations have expanded significantly under FDA and EU MDR frameworks. As compliance grows more complex, many organizations rely on post market surveillance consulting to support reporting, documentation, and continuous regulatory alignment. Why Post-Market Surveillance Matters PMS provides evidence that a device remains safe and effective throughout its entire lifecycle—not only during development and premarket evaluation. The process includes collecting real-world data, analyzing trends, and updating risk files, labeling, or documentation when needed. A strong PMS system helps manufacturers: Detect device performance trends early Prevent complaints from escalating into safety issues Maintain compliance with FDA and EU MDR requ...