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
What Are Early Recall Alerts?
Recall Communication “Early Alerts” Note: This summary is based on an FDA communication attributed to Michelle Tarver,...
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...
Cosmetic Products
FDA Regulation of Cosmetic Products Cosmetics are a part of daily life for millions of people—but what many consumers and...
Mechanical Circulatory Support (MCS) Devices
Overview of MCS Devices Mechanical Circulatory Support (MCS) devices have transformed the landscape of advanced heart...
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...
Avanos Recalls Ballard Closed Suction Systems
May result in non-sterile devices Avanos Medical, Inc. is recalling its Ballard Closed Suction Systems after identifying a...
The FDA Orphan Drug Program
Incentives for Rare Disease Drug Development The FDA’s Orphan Drug Program was established to encourage the development of...
FDA Grants Accelerated Approval to Multiple Myeloma Treatment
For hard-to-treat multiple myeloma On July 2, 2025, the FDA granted accelerated approval to linvoseltamab-gcpt (brand name:...
FDA Approves Alhemo for Patients with Hemophilia A or B
For Patients with Hemophilia A or B with Inhibitors The FDA has approved Alhemo (concizumab-mtci) for routine prophylaxis...
First-in-Class Non-Opioid Pain Reliever: Journavx
A new non-opioid pain treatment option On January 30, 2025, the FDA granted priority review for Journavx (suzetrigine) – a...