About Us
Medical Devices and Pharma LLC is a professional provider of expert regulatory consulting services for manufacturers of medical devices and pharmaceutical products regulated by the United States Food and Drug Administration (FDA), Health Canada, the European Union (EU), and globally.
This webpage not only provides regulatory information and assistance, but it is also a consumer-oriented resource designed to present timely safety news, helpful information, and analysis for users of medical devices and pharmaceutical products.
Our Mission
The mission of Medical Devices and Pharma is to provide the highest quality personalized professional regulatory services to our clients.
We maintain vigilance and provide timely safety information to consumers of medical device and pharmaceutical products, and provide insight and guidance to companies in FDA-regulated industries regarding their products, processes, innovation, product safety, and enforcement.
Who We Serve
We proudly support:
- Medical Device Manufacturers seeking compliance with QMSR and ISO 13485
- Startups and SMEs navigating FDA regulatory requirements for the first time
- Regulatory and Quality Professionals looking to expand their expertise
- Educational Institutions preparing the next generation of regulatory experts
Regulatory and Quality Information at Your Fingertips
We designed the Medical Devices and Pharma website to present critical industry information in a well-organized and easy-to-navigate format. We stay up-to-date with regulatory agency announcements and activities, so visitors to the site will see current information about medical devices, pharmaceuticals, biologics, combination products, and other regulated medical products.
Contact us
We are available to respond to regulatory questions, strategies, or managed projects. Do you have regulatory questions about your medical device or pharmaceutical product? Let us know – please contact us and we can provide regulatory guidance and advice for upcoming regulatory projects.
Regulatory and Quality Headlines
Affected Regulations and Standards
QMSR-Related Regulations and Standards The transition from the FDA’s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) marks a significant shift in how medical device manufacturers align with global quality standards. This page...
ISO 9000 Clause 3 Definitions
Establishing a Common Language for Quality Management Systems ISO 9000:2015, Quality management systems — Fundamentals and vocabulary, serves as the cornerstone of the ISO 9000 family of standards, providing essential terminology and principles for quality management...
QMSR – Overview of Changes
QMSR Implementation The U.S. Food and Drug Administration (FDA) has introduced significant updates to its regulatory framework for medical device manufacturers with the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation...
QMSR Integration
QMSR Integration The integration of FDA Quality System Regulation (QSR) requirements into ISO 13485:2016 provides a unified approach for medical device manufacturers to align with global standards while meeting U.S. regulatory requirements. The FDA's Quality...
QMSR Definitions and Vocabulary
QMSR Definitions The transition to the FDA’s new Quality Management System Regulation (QMSR) brings updated terminology and definitions that are crucial for ensuring compliance. Whether you’re new to regulatory requirements or transitioning from the Quality System...
QMSR for Small Manufacturers
Streamlined FDA QMSR Consulting for Small Manufacturers Navigating the FDA's new Quality Management System Regulation (QMSR) can be a challenge for small medical device manufacturers, but compliance doesn’t have to be overwhelming. At Medical Devices and Pharma (MDP),...
Request QMSR Information
QMSR Information Request Form Are you ready for the FDA’s transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR)? The new QMSR framework aligns more closely with ISO 13485, bringing significant changes to how medical...
QMSR Purchasing Controls
Available in paperback and eBook formats on Amazon. Click on the image or this link to see the book on the Amazon website.Starting on February 2, 2026, most medical device companies who sell their devices in the United States must comply with FDA’s new Quality...
FDA QMSR: Overview of the ISO 13485 Standard
Starting on February 2, 2026, most medical device companies who sell their devices in the United States must comply with FDA’s new Quality Management System Regulation (QMSR, 21 CFR 820), which on that day will replace the current Quality System Regulation (QSR, 21...
QMSR Frequently Asked Questions
Although the FDA has done an excellent job of laying out QMSR requirements and explaining differences between the QSR and the QMSR, there are questions related to the implementation of the new Quality Management System Regulation (QMSR) that need an answer. This page...