Safety Management
Workplace Safety
Medical Devices
Various inspection guides used by FDA field staff for audits. Mammography facility regulatory guidance. US Food and Drug Administration guidance on the CDRH requirements related to medical device manufacturing safety requirements - recalls, reporting, quality, use errors, etc.
medical devices, medical device safety
Represent manufacturers of medical devices
Create medical instrumentation standards
FDA guidance on the basic regulatory requirements that all manufacturers and importers must consider
The experience of a medical device company
Articles on quality assurance and control for medical device safety
An effective quality system must integrate risk management, customer satisfaction, and continuous improvement
US FDA requirements for ionizing and non-ionizing products, including medical products
Procedures options for U.S. firms to export both approved and unapproved medical devices
Certain steps during the design process can reduce a manufacturer's risk
FDA regulation of all aspects of in-home and laboratory diagnostic tests (in vitro diagnostic devices, or IVDs)
FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities
Most Popular Medical Device Guidance Documents
Guidance to FDA inspectors on medical device Quality System/GMP Regulation (QS/GMP) audits
Guidance to the FDA field staff conducting bioresearch monitoring inspections for IVD devices
This guidance document represents the FDA's current thinking on MQSA audits
Guidance to the FDA field staff to assess a medical device manufacturer's compliance
Guidance to FDA investigators regarding EMC & how it's addressed in a manufacturer's QS/QMP
Provide FDA personnel with technical background in a specific piece of equipment
Guidance on FDA medical device labeling requirements
501(k)s, PMAs, GGP, MDR, MAUDE, NHRIC and other FDA medical device databases
Manual to assist small business manufacturers of medical devices in FDA compliance
Mechanism for FDA to identify and monitor significant adverse events involving medical devices
The Good Manufacturing Practice (GMP) (also known as the Quality System Regulation) - FDA requirements
The benefits of implementing HACCP into a product development and manufacturing process are well worth the effort
Provides an overview of the standard - does not provide the text of the standard
Information for Manufacturers and Distributors on medical device labeling, etc.
Primer to improve the safety of medical devices by reducing likelihood of user error
Incorporating Human Factors Engineering into Risk Management
Information on in-home diagnostic tests (in vitro diagnostic devices, or IVDs)
FDA premarket notification [510(k)] requirements for In Vitro medical devices
Documents including worksheets to assists medical device manufacturers with HACCP plan implementation
A repository of medical device incident and hazard information
A series of articles on complying with standards that affect the medical device industry
Federal Register notices, fees, forms, guidance documents, reports
![[pdf]](graphics/file_pdf.gif){kind=small}
Implementation of the Mammography Quality Standards Act of 1992 (MQSA) - inspections
Manufacturers must follow certain requirements and regulations once devices are on the market
FDA Good Manufacturing Practice (GMP) Requirements Quality System (QS) Regulation Information
Failure modes and effects analysis can be a helpful tool in risk management for medical devices but has traps
Requirements of the Food and Drug Administration Amendments Act of 2007 for unique device identifiers
FDA Guidance for Industry - Wireless Medical Telemetry Risks and Recommendations
I'm looking for...
You win some, you lose some, and some get rained out,
Chemical Labeling
