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.
Our website 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
QMSR Purchasing Controls
Comparison of QSR and QMSR requirements for Purchasing Controls Starting on February 2, 2026, most medical device companies...
QMSR Frequently Asked Questions
Although the FDA has done an excellent job of laying out QMSR requirements and explaining differences between the QSR and...
EU MDR Compliance Consulting Services
Medical Devices and Pharma offers comprehensive services to help your business meet the stringent requirements of the EU...
Extensions for EU MDR and IVDR Implementation
Initial EU MDR and IVDR transition periods extended In 2023, the European Union granted an extension for the...
Implementation of the EU MDR and IVDR
A Significant EU Regulatory System Overhaul The implementation of the European Union's Medical Device Regulation (MDR) and...
FDA Grants Accelerated Approval to Tarlatamab-dlle
Treatment for lung cancer with progression following platinum-based chemotherapy On May 16, 2024, the Food and Drug...
FDA Approves New Imaging Drug Lumisight
A Significant Improvement for Surgical Oncology The U.S. Food and Drug Administration (FDA) has granted approval to...
FDA Issues Warning on Counterfeit Botox Products
Real Botox PackagingReal Botox Cosmetic PackagingReal Botox PackagingCounterfeit Botox Products The U.S. Food and Drug...
FDA Approves XACT Carotid Stent System
A Breakthrough for Stroke Prevention Abbott Vascular Inc. has received FDA approval for its groundbreaking XACT Carotid...
FDA Approves Xolremdi for WHIM Syndrome
A Breakthrough for Rare Infections In a groundbreaking development, the U.S. Food and Drug Administration (FDA) has...