Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationWelcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
Medical Devices
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The Latest Posts
Postmarket Surveillance
What is Postmarket Surveillance (PMS)? Postmarket surveillance (PMS) refers to all activities carried out by manufacturers to monitor the performance, safety, and effectiveness of a medical device after it has been placed on the market. It includes collecting and...
Medical Device Labeling
In the world of medical devices, proper labeling isn't just a regulatory requirement, it is a vital component of patient safety, product usability, and market access. Whether you're a manufacturer navigating FDA regulations, a distributor handling multilingual...
QMSR Clause 8 – Measurement Analysis and Improvement
ISO 13485 Clause 8 Transition Notes The QMSR eliminates FDA-specific structure in favor of ISO 13485:2016 clauses. All above ISO 13485 clauses are now explicit requirements under QMSR. New documentation and risk-based decision-making are emphasized throughout the...
QMSR Clause 7 – Product Realization
ISO 13485 Clause 7 - Product Realization Clause 7 of ISO 13485, titled Product Realization, outlines the structured approach medical device manufacturers must take to design, develop, produce, and deliver devices that meet customer needs and regulatory requirements....
QMSR Clause 6 – Resource Management
ISO 13485 Clause 6 - Resource Management Like other QSR-to-QMSR transition themes, there is a close alignment between 21 CFR 820.20(b), 820.25, and 820.70 ISO 13485 Clause 6 in their subjects of resources, personnel, training and documentation, awareness of work...
The Role of a Regulatory Professional
510(k) Submissions The New QSMR Regulatory Intelligence RIM Systems Regulatory Competencies Regulatory and Quality Role of Regulatory Professionals: Core Responsibilities Regulatory professionals play a critical role in ensuring that medical devices and pharmaceutical...