Medical Devices and Pharma
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Approvals for FDA Breakthrough Devices
Innovative Devices for Unmet Needs The Food and Drug Administration (FDA) has made a positive decision on the marketing applications of the following products. What sets them apart? They are innovative devices that qualified and participated in FDA's Breakthough...
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 devices called fixed (non-removable) palatal expanders, which are used on adults for jaw remodeling or to treat conditions like obstructive sleep...
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 Drug Administration (FDA) issued an update to its March 8 safety communication regarding reports of squamous cell carcinoma (SCC) and lymphomas in...
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 Drug Administration (FDA) issued a safety communication concerning reports of squamous cell carcinoma (SCC) and various types of lymphomas in the...
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QMSR Design Verification and Validation
ISO 13485:2016 Design and Development Clause 7.3 - Design and DevelopmentClause 7.3.1 - GeneralClause 7.3.2 - Design and...
QMSR Design and Development Reviews
ISO 13485:2016 Clause 7.3 - Design and DevelopmentClause 7.3.1 - GeneralClause 7.3.2 - Design and development...
QMSR Design and Development – Design Inputs and Outputs
ISO 13485:2016 Design and Development Clause 7.3 - Design and DevelopmentClause 7.3.1 - GeneralClause 7.3.2 - Design and...
QMSR Design and Development Controls
From Design Control to Design and Development Both the QSR and QMSR have the same design and development phases of...
Affected Regulations and Standards
QMSR-Related Regulations and Standards The transition from the FDA’s Quality System Regulation (QSR) to the Quality...
ISO 9000 Clause 3 Definitions
Establishing a Common Language for Quality Management Systems ISO 9000:2015, Quality management systems — Fundamentals and...
Welcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
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