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
FDA Early Alert for Baxter Intravascular Administration Sets
Healthcare facilities are instructed to immediately stop using affected IV solution sets while FDA evaluates the...
Why the Sudden Focus on Testosterone?
New Military Screening Program Raises Questions About Science, Strategy and TransparencyThe Trump administration's decision...
FDA Warning Letter Cites Illegal Drug Residue Levels in Dairy Cow
Letter Highlights FDA's Role in Protecting the Food Supply from Excessive Drug Residues When most people think about food...
FDA Warning Letter Targets Unapproved Fish and Bird Antibiotics
Letter Cites Unapproved Animal Drugs, Misbranding, and Antimicrobial Stewardship Concerns The U.S. Food and Drug...
Class I Recall for Bolton Medical RelayPro Thoracic Stent Graft
FDA Issues Class I Recall for RelayPro Thoracic Stent Graft Following Three Patient DeathsDeployment failure during aortic...
Arrow Corrects Kits With Recalled Injectable Medications
FDA Classifies Field Correction As Class I Recall Due to Risk of Serious Injury The U.S. Food and Drug Administration (FDA)...
Casgevy Gene Therapy Expanded to 2-Year-Old Children
FDA Expands Casgevy Gene Therapy Approval to Children as Young as 2 with Sickle Cell DiseaseFirst CRISPR-based gene therapy...
FDA Issues Early Alert for Resmed Astral Ventilators
Resmed VentilatorPatients should continue using devices unless instructed otherwise by their healthcare provider The U.S....
FDA Approves First Oral PCSK9 Inhibitor for High Cholesterol
FDA Approves Lipfendra, the First Oral PCSK9 Inhibitor for High CholesterolLipfendra offers patients a once-daily pill...
FDA Approves Retevmo for RET Fusion-Positive Solid Tumors
FDA Grants Full Approval to Retevmo for RET Fusion-Positive Metastatic Solid TumorsApproval expands precision medicine...