Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
Expert guidance for industry professionals and clear, reliable information for patients and consumers
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Regulatory Documentation for National and Global Market Access
With a solid base of technical documentation, our regulatory specialists will prepare a regulatory submission that is organized, well written, complete, and meets the regulatory requirements of the agency that will evaluate the product.
FDA Information – Conveniently Organized and Accessible
Quickly find the FDA information you need Conveniently organized FDA information. The U.S. Food and Drug Administration (FDA) provides a wealth of information for consumers and industry stakeholders. The problem is, it can be difficult to navigate to the information...
FDA Announces Online Electronic 510(k) Submissions
The U.S. Food and Drug Administration (FDA) announced the issuance of its final guidance document for its template for electronic 510(k) submissions on September 22, 2022. The electronic Submission Template and Resource (eSTAR) electronic submissions template is a...
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QMSR Design and Development Controls
From Design Control to Design and Development Both the QSR and QMSR have the same design and development phases of...
Affected Regulations and Standards
QMSR-Related Regulations and Standards The transition from the FDA’s Quality System Regulation (QSR) to the Quality...
ISO 9000 Clause 3 Definitions
Establishing a Common Language for Quality Management Systems ISO 9000:2015, Quality management systems — Fundamentals and...
QMSR – Overview of Changes
QMSR Implementation The U.S. Food and Drug Administration (FDA) has introduced significant updates to its regulatory...
Request QMSR Information
QMSR Information Request Form Are you ready for the FDA’s transition from the Quality System Regulation (QSR) to the...
QMSR Purchasing Controls
Comparison of QSR and QMSR requirements for Purchasing Controls Starting on February 2, 2026, most medical device companies...
Welcome 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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