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
Asensus Surgical Inc Issues Recall for Senhance Surgical System
Class I Recall Notice Asensus Surgical Inc. has announced a recall for its Senhance Surgical System due to malfunctions leading to unintended movement of the robotically-assisted surgical device. Device Use The Senhance Surgical System is a vital tool utilized in...
Datex-Ohmeda Issues Field Correction for EVair Air Compressors
Urgent Class I Recall Notice Datex-Ohmeda Inc. has announced a field correction for its EVair and Jun-air compressors, optional ventilator accessories designed to provide an alternative source of airflow for patient support in clinical settings where wall air is...
Differences between BiPAP and CPAP
What Are the Differences between BiPAP and CPAP Machines? BiPAP (Bilevel Positive Airway Pressure) and CPAP (Continuous Positive Airway Pressure) machines are both commonly used to treat sleep apnea, a condition where breathing repeatedly stops and starts during...
CPAP Machines
What Is a CPAP Machine? A CPAP (Continuous Positive Airway Pressure) machine is a medical device used primarily to treat sleep apnea, a condition characterized by pauses in breathing or shallow breaths during sleep. CPAP therapy involves delivering a continuous...
FDA Approves Versatile Antibiotic Zevtera for Three Key Infections
FDA Approves Versatile Antibiotic Zevtera for Three Key Infections The U.S. Food and Drug Administration (FDA) announced today that the fight against bacterial infections has gained a significant boost with the recent approval of Zevtera (ceftobiprole medocaril...
Urgent Recall Notice for ARROW QuickFlash Catheterization Kits
Urgent Recall Notice for ARROW QuickFlash Catheterization Kits In February 2024, Teleflex and its subsidiary Arrow International issued an urgent recall notice for the ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits. Today, a...
Plastic Syringe Safety: FDA’s Ongoing Evaluation
Today, the U.S. Food and Drug Administration (FDA) provided a crucial update regarding the quality and performance issues associated with plastic syringes made in China. This announcement follows the agency's previous safety communication issued on November 30, 2023,...
Original FDA Safety Warning for China-made Syringes
In an announcement dated November 30, 2023, the U.S. Food and Drug Administration (FDA) issued a notice regarding the evaluation of potential device failures associated with plastic syringes manufactured in China. The FDA is actively collecting and analyzing data to...
AvKARE Recalls Atovaquone Oral Suspension
AvKARE Recalls Atovaquone Oral Suspension AvKARE, LLC has issued a voluntary recall of lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL due to potential Bacillus cereus contamination found during stability testing at a third-party lab. The affected...
FDA Warns of Risks with OTC Pain Relief Products
The U.S. Food and Drug Administration (FDA) has issued a stern warning to consumers regarding the use of certain over-the-counter analgesic (pain relief) products intended for topical use before, during, or after various cosmetic procedures like microdermabrasion,...