Health Care Safety » Medical Devices
US Food and Drug Administration guidance on the CDRH requirements related to medical device manufacturing safety requirements - recalls, reporting, quality, use errors, etc. Various inspection guides used by FDA field staff for audits. Mammography facility regulatory guidance.
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Hot Topics: Industry: Health Care, Management: General
Professional Guides: Business Manager, Human Resources Manager, Industry Guides, Risk Manager
AdvaMed - Advanced Medical Technology Association [26980] 
Represent manufacturers of medical devices
Represent manufacturers of medical devices
Anesthesia Apparatus Checkout Recommendations [16455]
Design to be conducted before administration of anesthesia
Design to be conducted before administration of anesthesia
Association for the Advancement of Medical Instrumentation [16457]
Create medical instrumentation standards
Create medical instrumentation standards
Background Information for International Officials: Medical Device Regulation [16487]
FDA guidance on the basic regulatory requirements that all manufacturers and importers must consider
FDA guidance on the basic regulatory requirements that all manufacturers and importers must consider
Design Control Guidance for Medical Device Manufacturers [16472]
Assists manufacturers in understanding quality system requirements concerning design controls
Assists manufacturers in understanding quality system requirements concerning design controls
Design Control Practices for IVDs [26572]
Since FDA’s QSR and the ISO standards are essentially the same, a single design-control process can satisfy both
Since FDA’s QSR and the ISO standards are essentially the same, a single design-control process can satisfy both
Developing a Comprehensive Quality System [26573]
Regulatory outlook for medical device safety risk management - June, 2004
Regulatory outlook for medical device safety risk management - June, 2004
Developing a HACCP Plan to Reduce Inspection Time [25396]
1998 article on one of the FDA pilot program companies that implemented a HACCP plan to reduce inspection time
1998 article on one of the FDA pilot program companies that implemented a HACCP plan to reduce inspection time
Device Advice from the FDA's CDRH [16489]
Self-service site for medical device and radiation emitting product information
Self-service site for medical device and radiation emitting product information
Electronic Product Radiation Control [22446]
US FDA requirements for ionizing and non-ionizing products, including medical products
US FDA requirements for ionizing and non-ionizing products, including medical products
Establishing Overall Risk for Medical Devices [25400]
Article on developing an overall risk index in accordance with ISO/IEC 14971, Clause 7
Article on developing an overall risk index in accordance with ISO/IEC 14971, Clause 7
Exporting Medical Devices [16495]
Procedures options for U.S. firms to export both approved and unapproved medical devices
Procedures options for U.S. firms to export both approved and unapproved medical devices
FDA - Diagnostic Tests [29093]
Information on all aspects of in-home and laboratory diagnostic tests (in vitro diagnostic devices, or IVDs)
Information on all aspects of in-home and laboratory diagnostic tests (in vitro diagnostic devices, or IVDs)
FDA Electromagnetic Compatibility Program [24730]
FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities
FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities
FDA Inspection Guide of Medical Device Manufacturers [16465]
Guidance to FDA inspectors on medical device Quality System/GMP Regulation (QS/GMP) audits
Guidance to FDA inspectors on medical device Quality System/GMP Regulation (QS/GMP) audits
FDA Inspection Guide to Bioresearch Monitoring of In Vitro Diagnostic Devices [16463]
Guidance to the FDA field staff conducting bioresearch monitoring inspections for IVD devices
Guidance to the FDA field staff conducting bioresearch monitoring inspections for IVD devices
FDA Inspection Guide: Mammography Quality Standards Act Auditor's Guide [16464]
This guidance document represents the FDA's current thinking on MQSA audits
This guidance document represents the FDA's current thinking on MQSA audits
FDA Inspection Handbook: Guide to Inspections of Quality Systems (QSIT) [16461]
Guidance to the FDA field staff to assess a medical device manufacturer's compliance
Guidance to the FDA field staff to assess a medical device manufacturer's compliance
FDA Inspection of Electromagnetic Compatibility Aspects of Medical Device Qualit [16462]
Guidance to FDA investigators regarding EMC & how it's addressed in a manufacturer's QS/QMP
Guidance to FDA investigators regarding EMC & how it's addressed in a manufacturer's QS/QMP
FDA Inspector's Technical Guides [16466]
Provide FDA personnel with technical background in a specific piece of equipment
Provide FDA personnel with technical background in a specific piece of equipment
FDA Medical Device Quality Systems Manual - Small Entity Guide [16469]
Manual to assist small business manufacturers of medical devices in FDA compliance
Manual to assist small business manufacturers of medical devices in FDA compliance
FDA Medical Device Reporting [16482]
Mechanism for FDA to identify and monitor significant adverse events involving medical devices
Mechanism for FDA to identify and monitor significant adverse events involving medical devices
Final Rule: Current Good Manufacturing Practice (CGMP) - Medical Devices [16470]
The Good Manufacturing Practice (GMP) (also known as the Quality System Regulation) Final Rule
The Good Manufacturing Practice (GMP) (also known as the Quality System Regulation) Final Rule
GMP Reference Information for Medical Devices [16467]
FDA Good Manufacturing Practice (GMP) Requirements Quality System (QS) Regulation Information
FDA Good Manufacturing Practice (GMP) Requirements Quality System (QS) Regulation Information
HACCP: Resolving Medical Product Safety and Liability Nightmares [25395]
The benefits of implementing HACCP into a product development and manufacturing process are well worth the effort
The benefits of implementing HACCP into a product development and manufacturing process are well worth the effort
HE74:2001 Human Factors Design Process for Medical Devices [24260]
Provides an overview of the standard - does not provide the text of the standard
Provides an overview of the standard - does not provide the text of the standard
Human Factors & Medical Devices [16454]
Information for Manufacturers and Distributors on medical device labeling, etc.
Information for Manufacturers and Distributors on medical device labeling, etc.
Human Factors in Medical Devices Primer [16468]
Primer to improve the safety of medical devices by reducing likelihood of user error
Primer to improve the safety of medical devices by reducing likelihood of user error
Human Factors in Medical Devices: Design, Regulation, and Patient Safety [1283]
Papers that discuss human factors and medical devices
Papers that discuss human factors and medical devices
Human Factors Program - CDRH [16456]
Human factors guidance from the FDA's Center for Devices & Radiological Health
Human factors guidance from the FDA's Center for Devices & Radiological Health
Identifying and Understanding Medical Device Use Errors [16473]
Checklist for identifying errors resulting from the use of medical devices
Checklist for identifying errors resulting from the use of medical devices
In Vitro Diagnostic Device Over the Counter OTC Database [29094]
Information on in-home diagnostic tests (in vitro diagnostic devices, or IVDs)
Information on in-home diagnostic tests (in vitro diagnostic devices, or IVDs)
In Vitro Diagnostic Devices: Guidance for Preparation of 501(k) Submissions [16486]
This manual covers FDA premarket notification [510(k)] requirements for In Vitro medical devices
This manual covers FDA premarket notification [510(k)] requirements for In Vitro medical devices
Integrating Risk Management with Design Control [25398]
Making a risk management program part of a company's design control procedures improves device safety
Making a risk management program part of a company's design control procedures improves device safety
IVD Directive & Risk Management Requirements [25399]
Article on complying with the risk management requirements of the IVD Directive
Article on complying with the risk management requirements of the IVD Directive
IVD Directive: Preparing Technical Documentation [26574]
A step-by-step approach may simplify the task of preparing technical documentation
A step-by-step approach may simplify the task of preparing technical documentation
Labeling Requirements of Medical Devices [16492]
Guidance on FDA medical device labeling requirements
Guidance on FDA medical device labeling requirements
Medical Device HACCP Implementation [25394]
Documents including worksheets to assists medical device manufacturers with HACCP plan implementation
Documents including worksheets to assists medical device manufacturers with HACCP plan implementation
Medical Device Safety Reports [14751]
A repository of medical device incident and hazard information
A repository of medical device incident and hazard information
Medical Device User Fee and Modernization Act (MDUFMA) of 2002 [22453]
Text of the act signed into law October 26, 2002
Text of the act signed into law October 26, 2002
MQSA FDA Inspection Guide: Mammography Facilities [16474]
Implementation of the Mammography Quality Standards Act of 1992 (MQSA) - inspections
Implementation of the Mammography Quality Standards Act of 1992 (MQSA) - inspections
Post-production Risk Management [26571]
Applying HACCP principles can minimize the introduction of risk factors in medical device safety
Applying HACCP principles can minimize the introduction of risk factors in medical device safety
Premarket Approval Requirements [16483]
Intended to aid applicants in the preparation of a PMA as required by the FDA
Intended to aid applicants in the preparation of a PMA as required by the FDA
Project Management Equals Risk Management [26575]
Initial risk assessment can benefit medical device product development
Initial risk assessment can benefit medical device product development
Recalls of Medical Devices [16490]
Make a report to FDA if the product correction or removal involves a "risk to health"
Make a report to FDA if the product correction or removal involves a "risk to health"
Reporting Problems with Medical Devices [13484]
Guidance regarding FDA's Safe Medical Device Act of 1990 (SMDA) requirements
Guidance regarding FDA's Safe Medical Device Act of 1990 (SMDA) requirements
The Use & Misuse of FMEA in Risk analysis [26570]
Failure modes and effects analysis can be a helpful tool in risk management for medical devices but has traps
Failure modes and effects analysis can be a helpful tool in risk management for medical devices but has traps
Tracking of Medical Devices [16491]
Manufacturer tracking of certain devices from their manufacture through the distribution chain
Manufacturer tracking of certain devices from their manufacture through the distribution chain
Wireless Medical Telemetry - Electromagnetic Interference Concerns and Solutions [24732]
Wireless Medical Telemetry Risks and Recommendations
Wireless Medical Telemetry Risks and Recommendations
Related Categories within The Safety Library
View All Related Categories throughout the Libraries & Directories
Health Care Safety / Malpractice
Medical malpractice, risk management in medicine, insurance, etc.
Health Care Safety / Needlestick Injuries
Needlestick injury prevention, legislation, safety devices
Health Care Safety / Patient Safety
Medical errors, medication errors, patient safety guidance
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