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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There are 33 other categories related to Health Care Safety / Medical Devices in the Libraries & Directories.

AdvaMed - Advanced Medical Technology Association [26980] Location
Represent manufacturers of medical devices

Anesthesia Apparatus Checkout Recommendations [16455] Location
Design to be conducted before administration of anesthesia

Association for the Advancement of Medical Instrumentation [16457] Location
Create medical instrumentation standards

Background Information for International Officials: Medical Device Regulation [16487] Location
FDA guidance on the basic regulatory requirements that all manufacturers and importers must consider

CDRH Databases [16488] Location
501(k)s, PMAs, GGP, MDR, MAUDE, NHRIC and other FDA medical device databases

Design Control Guidance for Medical Device Manufacturers [16472] Location
Assists manufacturers in understanding quality system requirements concerning design controls

Design Control Practices for IVDs [26572] Location
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] Location
Regulatory outlook for medical device safety risk management - June, 2004

Developing a HACCP Plan to Reduce Inspection Time [25396] Location
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] Location
Self-service site for medical device and radiation emitting product information

ECRI Medical Device Problem Reporting [24285] Location
How to report a problem to ECRI and to the FDA

Electronic Product Radiation Control [22446] Location
US FDA requirements for ionizing and non-ionizing products, including medical products

Establishing Overall Risk for Medical Devices [25400] Location
Article on developing an overall risk index in accordance with ISO/IEC 14971, Clause 7

Exporting Medical Devices [16495] Location
Procedures options for U.S. firms to export both approved and unapproved medical devices

FDA - Diagnostic Tests [29093] Location
Information on all aspects of in-home and laboratory diagnostic tests (in vitro diagnostic devices, or IVDs)

FDA Databases [25401] Location
Databases of interest to medical device manufacturers

FDA Electromagnetic Compatibility Program [24730] Location
FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities

FDA Inspection Guide of Medical Device Manufacturers [16465] Location
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] Location
Guidance to the FDA field staff conducting bioresearch monitoring inspections for IVD devices

FDA Inspection Guide: Mammography Quality Standards Act Auditor's Guide [16464] Location
This guidance document represents the FDA's current thinking on MQSA audits

FDA Inspection Handbook: Guide to Inspections of Quality Systems (QSIT) [16461] Location
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] Location
Guidance to FDA investigators regarding EMC & how it's addressed in a manufacturer's QS/QMP

FDA Inspector's Technical Guides [16466] Location
Provide FDA personnel with technical background in a specific piece of equipment

FDA Medical Device Quality Systems Manual - Small Entity Guide [16469] Location
Manual to assist small business manufacturers of medical devices in FDA compliance

FDA Medical Device Reporting [16482] Location
Mechanism for FDA to identify and monitor significant adverse events involving medical devices

Final Rule: Current Good Manufacturing Practice (CGMP) - Medical Devices [16470] Location
The Good Manufacturing Practice (GMP) (also known as the Quality System Regulation) Final Rule

GMP Reference Information for Medical Devices [16467] Location
FDA Good Manufacturing Practice (GMP) Requirements Quality System (QS) Regulation Information

HACCP Worksheet [25397] Location
A sample form that can be used to help design a HACCP plan

HACCP: Resolving Medical Product Safety and Liability Nightmares [25395] Location
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] Location
Provides an overview of the standard - does not provide the text of the standard

Human Factors & Medical Devices [16454] Location
Information for Manufacturers and Distributors on medical device labeling, etc.

Human Factors in Medical Devices Primer [16468] Location
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] Location
Papers that discuss human factors and medical devices

Human Factors Program - CDRH [16456] Location
Human factors guidance from the FDA's Center for Devices & Radiological Health

Identifying and Understanding Medical Device Use Errors [16473] Location
Checklist for identifying errors resulting from the use of medical devices

In Vitro Diagnostic Device Over the Counter OTC Database [29094] Location
Information on in-home diagnostic tests (in vitro diagnostic devices, or IVDs)

In Vitro Diagnostic Devices: Guidance for Preparation of 501(k) Submissions [16486] Location
This manual covers FDA premarket notification [510(k)] requirements for In Vitro medical devices

Integrating Risk Management with Design Control [25398] Location
Making a risk management program part of a company's design control procedures improves device safety

IVD Directive & Risk Management Requirements [25399] Location
Article on complying with the risk management requirements of the IVD Directive

IVD Directive: Preparing Technical Documentation [26574] Location
A step-by-step approach may simplify the task of preparing technical documentation

Labeling Requirements of Medical Devices [16492] Location
Guidance on FDA medical device labeling requirements

Medical Device HACCP Implementation [25394] Location
Documents including worksheets to assists medical device manufacturers with HACCP plan implementation

Medical Device Safety Reports [14751] Location
A repository of medical device incident and hazard information

Medical Device User Fee and Modernization Act (MDUFMA) of 2002 [22453] Location
Text of the act signed into law October 26, 2002

Medical Glove Guidance Manual [16481] Location
FDA regulatory guidance on the marketing of medical gloves

MQSA FDA Inspection Guide: Mammography Facilities [16474] Location
Implementation of the Mammography Quality Standards Act of 1992 (MQSA) - inspections

MQSA Regulatory Guidance Documents [16477] Location
FDA compliance guidance for mammography facilities

Post-production Risk Management [26571] Location
Applying HACCP principles can minimize the introduction of risk factors in medical device safety

Premarket Approval Requirements [16483] Location
Intended to aid applicants in the preparation of a PMA as required by the FDA

Premarket Notification 510(k) Review Fees [16484] Location
Guidance, forms and fee information

Project Management Equals Risk Management [26575] Location
Initial risk assessment can benefit medical device product development

Radiation Emitting Devices Labeling Requirements [16479] Location
Guidance on FDA requirements

Recalls of Medical Devices [16490] Location
Make a report to FDA if the product correction or removal involves a "risk to health"

Reporting Problems with Medical Devices [13484] Location
Guidance regarding FDA's Safe Medical Device Act of 1990 (SMDA) requirements

The Use & Misuse of FMEA in Risk analysis [26570] Location
Failure modes and effects analysis can be a helpful tool in risk management for medical devices but has traps

Tracking of Medical Devices [16491] Location
Manufacturer tracking of certain devices from their manufacture through the distribution chain

Wireless Medical Telemetry - Electromagnetic Interference Concerns and Solutions [24732] Location
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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