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
FDA Quality System Regulation – 21 CFR 820
QMSR CentralFDA Quality System Regulation – 21 CFR 820 21 CFR 820, also known as the Quality System Regulation (QSR), outlines the requirements for the establishment and maintenance of a quality management system for medical device manufacturers in the United States....
Edwards EVOQUE Tricuspid Valve Replacement System
Edwards EVOQUE Tricuspid Valve Replacement System In a groundbreaking move, the FDA has recently approved the Edwards EVOQUE Tricuspid Valve Replacement System for market distribution. The device was developed by Edwards Lifesciences LLC. This innovative system...
Device Overview – Spinal Cord Stimulation Systems
What Is an SCS System? A spinal cord stimulation (SCS) system is a medical device used to manage chronic pain by delivering electrical impulses to the spinal cord. The system typically consists of several components: Implantable Pulse Generator (IPG) This is the...
Prospera Spinal Cord Stimulation System for Intractable Back Pain
Prospera Spinal Cord Stimulation System FDA has recently approved the Prospera Spinal Cord Stimulation (SCS) System, developed by BIOTRONIK NRO, INC., as a treatment for chronic, difficult-to-manage pain in the trunk or limbs. This implanted system comprises a...
A Look at the CDRH 2024 Innovation Report
Revolutionizing Medical Device Innovation In a world where medical technology evolves at a rapid pace, ensuring patients have access to cutting-edge, safe, and effective devices is paramount. Yesterday, the Center for Devices and Radiological Health (CDRH) released...
CDRH Issues its 2024 Safety Report
2024 CDRH Safety Report The FDA Center for Devices and Regulatory Health issued its CDRH 2024 Safety Report on April 17, 2024. The report outlines the commitment of the Center for Devices and Radiological Health (CDRH) to ensuring the safety and effectiveness of...
Fresenius Kabi Recalls Ivenix Infusion Pump Software
Urgent Class I Recall Notice A crucial recall notice has been issued by Fresenius Kabi USA, LLC for the LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0, distributed between March 6, 2023, and March 20, 2024. The recall, initiated on March 7, 2024, is...
Urgent Recall for Boston Scientific Obsidio Conformable Embolic
Urgent Class I Recall Notice Boston Scientific Corporation issued a critical recall notice on February 20, 2024, for its Obsidio Conformable Embolic products. The recall affects products distributed between May 8, 2023, and February 8, 2024. Product Details ...
FDA – Do Not Use Non-piercing Devices to Measure Blood Glucose
FDA Safety Communication On February 21, 2024 the U.S. Food and Drug Administration (FDA) issued a safety communication regarding the use of smartwatches or smart rings that claim to measure blood glucose levels without the need for skin piercing. Its cautionary...
Medos International Recalls CEREBASE DA Guide Sheath
Urgent Class I Recall Notice Medos International Sàrl has issued an urgent recall for the Cerenovus CEREBASE DA Guide Sheath, a neurovascular catheter commonly used in procedures requiring precise navigation and access to blood vessels in the brain. The recall was...