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
Prodigy Proclaim Spinal Cord Stimulation Systems
Significant advancement for chronic pain treatment On February 15, 2023, the U.S. Food and Drug Administration (FDA)...
Exposure to toxic materials during hemodialysis and dialysis
FDA announcement The US Food and Drug Administration (FDA) issued an announcement on March 7 to update its May 2022 letter...
FDA Breakthrough Devices Program
FDA Breakthrough Devices Program The U.S. Food and Drug Administration (FDA) has established the Breakthrough Devices...
Approvals for FDA Breakthrough Devices
Innovative Devices for Unmet Needs The Food and Drug Administration (FDA) has made a positive decision on the marketing...
FDA Explores Dental Device Safety Concerns
Dental Devices to Treat Sleep Apnea and TMD The FDA is currently evaluating safety concerns related to certain dental...
Update – Carcinoma Inside Capsule of Breast Implants
Squamous Cell Carcinoma and Various Lymphomas Located in the Capsule around Breast Implants On March 22, the US Food and...
Carcinoma and Lymphomas Found Near Breast Implants
Squamous Cell Carcinoma and Various Lymphomas Located in the Capsule around Breast Implants On March 8, the US Food and...
A Team-based Approach to an Expedited 510(k)
Getting an expedited 510(k) submission So, you have created a new medical device by following your quality system’s design...
FDA Approves Lamzede for Treatment of Alpha-mannosidosis
The U.S. Food and Drug Administration (FDA) on February 17, 2023 announced the approval the first-ever enzyme replacement...
FDA Warning Letter to Olympus Medical Systems
Letter addresses several violations of FDA&C Act On March 15, 2023, the Food and Drug Administration (FDA) issued a...