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
Alert: Ventilator Systems Risk in Neonatal Tidal Volume Delivery
Maquet Servo Ventilator SystemsSource: FDAUrgent Class I Medical Device Correction Maquet Critical Care AB, a subsidiary of Getinge, has issued an urgent correction notice regarding its Servo Ventilator Systems (Servo-u, Servo-n, and Servo-u MR). This correction does...
Urgent Recall of Codman Disposable Perforators
Urgent Class I Medical Device Recall Integra LifeSciences has issued an urgent recall of specific Codman Disposable Perforators and Craniotomy Kits due to a serious manufacturing defect that may lead to device disassembly during neurosurgical procedures. The FDA has...
FDA Cracks Down on Insightra Medical
Warning Letter Cites a Number of Serious Violations In a scathing warning letter, the FDA has cited Insightra Medical, Inc. for widespread regulatory violations involving its Intra-Aortic Balloon Pump (IABP) Catheter Kit—a device used in critical cardiovascular...
FDA Cracks Down on Illegally Marketed 7-OH Products
Unapproved drugs sold online and in retail locations Yesterday the U.S. Food and Drug Administration (FDA) issued seven warning letters to companies marketing products that contain 7-hydroxymitragynine (7-OH) — a powerful and potentially dangerous opioid-like...
Sterile Drug Manufacturing Violations at Daewoo Pharmaceutical
FDA Cracks Down on Sterile Drug Manufacturing Violations The U.S. Food and Drug Administration (FDA) has issued a warning letter to Daewoo Pharmaceutical Co., Ltd. in Busan, South Korea, citing serious and widespread violations of current Good Manufacturing Practices...
What Are Early Recall Alerts?
Recall Communication “Early Alerts” Note: This summary is based on an FDA communication attributed to Michelle Tarver, M.D., Ph.D., director of the Center for Devices and Radiological Health (CDRH). In November 2024 the U.S. Food and Drug Administration’s Center for...
Urgent Recall Alert for BD Alaris Infusion Sets
Class I Recall (Correction) The FDA has issued an early alert to healthcare providers and patients regarding a performance issue affecting BD Alaris Pump Module model 8100, used with specific compatible infusion sets. BD, through its subsidiary CareFusion, has...
Cosmetic Products
FDA Regulation of Cosmetic Products Cosmetics are a part of daily life for millions of people—but what many consumers and businesses don’t realize is that cosmetic products are regulated by the U.S. Food and Drug Administration (FDA). While cosmetics do not require...
Mechanical Circulatory Support (MCS) Devices
Overview of MCS Devices Mechanical Circulatory Support (MCS) devices have transformed the landscape of advanced heart failure treatment. From temporary stabilization in cardiogenic shock to long-term support as destination therapy, these technologies bridge critical...
Recall Alert: AirLife/Vyaire Infant Breathing Systems
Class I Recall AirLife and manufacturer Vyaire are recalling specific Infant Heated Wire Circuits due to the risk that accessory adapters may disconnect during use, especially once the system reaches operating temperature. This could lead to serious injury or death,...