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
Class I Recall for Intra-Aortic Blood Pumps
Datascope/Getinge IABPs May Malfunction Due to Cable Failure The US Food and Drug Administration (FDA) announced yesterday...
Urgent Action Required – Baxter LIFE2000 System
Software issue can cause potential harm or death On March 10, the US Food and Drug Administration (FDA) announced that...
FDA Approves Rukabia for HIV Treatment
The U.S. Food and Drug Administration (FDA) on December 22, 2022 announced the approval of a new HIV drug called Rukobia...
FDA Warning Letter to Jackson Clinic
Warning Letter Sites Violations of Law In early February of this year, the U.S. Food and Drug Administration (FDA) issued...
FDA Approval for Cancer Treatment Aid
The Food and Drug Administration (FDA) on 12 December 2022 announced the approval of Agilent's Resolution CTDX FIRST, a new...
FDA Accelerated Approval for Alzheimer’s Disease Treatment
The US Food and Drug Administration (FDA) announced on 06 January, 2023 that it had granted accelerated approval for the...
FDA Posts Warning Letter to MicroVention Costa Rica
Identifies several violations of the FD&C Act and QSR On February 7, FDA issued a warning letter it had sent to...
FDA Issues Letter to Warn of Abbott Trifecta Valve Risks
Letter outlines risks associated with the heart valve On February 27, the FDA released a letter to healthcare providers...
FDA Announces Recall of GE Nuclear Medicine Systems
1200-pound Devices Could Fall on Patients On February 15, the FDA issued a statement announcing a recall of certain nuclear...
FDA announces recall of LivaNova LifeSPARC System
The US Food and Drug Administration (FDA) has announced a recall of the Livanova TandemLife LifeSparc System, a medical...