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, 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 and pharmaceuticals.
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
The Role of a Regulatory Professional
510(k) Submissions The New QSMR Regulatory Intelligence RIM Systems Regulatory Competencies Regulatory and Quality Role of Regulatory Professionals: Core Responsibilities Regulatory professionals play a critical role in ensuring that medical devices and pharmaceutical...
Urgent Recall: Dr. Reddy’s Levetiracetam Injection
What You Need to Know Dr. Reddy’s Laboratories has issued an urgent recall for one batch (Lot No: A1540076) of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL due to a serious labeling error. The infusion bag is incorrectly labeled as Levetiracetam...
FDA Issues Warning on Epinephrine Nasal Solutions
Left: BPI Labs’ FDA-approved Epinephrine Injection with blue lid on the bottle.Right: BPI Labs’ unapproved EPINEPHrine Chloride Nasal Solution with red lid on the bottle.Courtesy: FDA.A Potentially Dangerous Mix-Up The U.S. Food and Drug Administration (FDA) has...
QMSR Management Responsibility
Transitioning from QSR to QMSR – Management Responsibility The QMSR Management Responsibility requirements bring a more structured, documented, and proactive approach compared to QSR §820.20. While many concepts remain similar, organizations must focus on:✅ Stronger...
QMSR Quality Manual
Why This Matters in the QMSR Transition U.S. Manufacturers Adopting ISO 13485 Will Need a Quality Manual While QMSR does not mandate a Quality Manual, ISO 13485 compliance does—meaning manufacturers aligning with QMSR will likely need to create one. Many U.S. medical...
QMSR Quality Management System Requirements
Overview of QMSR Quality Management System Requirements The QMSR (Quality Management System Regulation) under 21 CFR 820.10 aligns U.S. medical device manufacturers with ISO 13485 while maintaining FDA-specific requirements. This hybrid framework ensures international...
QMSR Clauses 1 and 2 – Scope and Normative References
ISO 13485 Clause 1 and Clause 2 For medical device manufacturers, compliance with ISO 13485:2016 is essential to ensure the quality, safety, and regulatory alignment of their products. The first two clauses of the standard lay the groundwork for understanding its...
Generic Eliquis
Generic Eliquis Editor's note: FDA originally announced the approval of generic equivalents to Eliquis in 2019, and updated that information the next year. We are publishing this information as a response to reader requests for more information about generic Eliquis....
QMSR Design and Development Transfer and Changes
ISO 13485:2016 Clause 7.3 - Design and DevelopmentClause 7.3.1 - GeneralClause 7.3.2 - Design and development planningClause 7.3.3 - Design and development inputsClause 7.3.4 - Design and development outputsClause 7.3.5 - Design and development reviewClause 7.3.6 -...
QMSR Design Verification and Validation
ISO 13485:2016 Clause 7.3 - Design and DevelopmentClause 7.3.1 - GeneralClause 7.3.2 - Design and development planningClause 7.3.3 - Design and development inputsClause 7.3.4 - Design and development outputsClause 7.3.5 - Design and development reviewClause 7.3.6 -...