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

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

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

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

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

Developing a Comprehensive Quality System [26573]
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

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

Updated Electronic Product Radiation Control [22446]
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

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

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

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

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

Updated FDA Guidance Documents for Medical Device Manufacturers [16472]
Most Popular Medical Device Guidance Documents

Updated FDA Inspection Guide of Medical Device Manufacturers [16465]
Guidance to FDA inspectors on medical device Quality System/GMP Regulation (QS/GMP) audits

Updated 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

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

Updated 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

Updated FDA Inspection of Electromagnetic Compatibility Aspects of Medical Device Quality [16462]
Guidance to FDA investigators regarding EMC & how it's addressed in a manufacturer's QS/QMP

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

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

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

Updated FDA Medical Device Guidance Documents [16489]
Good guidance practice documents

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

Updated FDA Medical Device Reporting - Event Problem Codes [16482]
Mechanism for FDA to identify and monitor significant adverse events involving medical devices

Updated FDA Medical Device User Fee and Modernization Act Fees [16484]
Guidance, forms and fee information

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

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

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

HE74:2001 Human Factors Design Process for Medical Devices [24260]
Provides an overview of the standard - does not provide the text of the standard

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

Updated Human Factors in Medical Devices Primer [16468]
Primer to improve the safety of medical devices by reducing likelihood of user error

Updated Human Factors in Medical Devices: Design, Regulation, and Patient Safety [1283]
Papers that discuss human factors and medical devices

Updated Human Factors Program - FDA Medical Devices [16456]
Human factors guidance from the FDA

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

Updated In Vitro Diagnostic Devices: Guidance for Preparation of 501(k) Submissions [16486]
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

IVD Directive & Risk Management Requirements [25399]
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

Medical Device HACCP Implementation [25394]
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

Updated Medical Device User Fee and Modernization Act (MDUFMA) of 2002 [22453]
Federal Register notices, fees, forms, guidance documents, reports

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

Updated Medical Imaging - FDA Requirements [16473]
Laws, regulations, industr guidance and more

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

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

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

Updated Postmarket Medical Device Requirements [16483]
Manufacturers must follow certain requirements and regulations once devices are on the market

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

Updated Quality System (QS) Regulation/Medical Device Good Manufacturing Practices [16467]
FDA Good Manufacturing Practice (GMP) Requirements Quality System (QS) Regulation Information

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

Updated Recalls of Medical Devices [16490]
FDA database of medical device recalls

Updated Reporting Problems with Medical Devices [13484]
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

Updated Tracking of Medical Devices - Unique Device Identifiers [16491]
Requirements of the Food and Drug Administration Amendments Act of 2007 for unique device identifiers

Updated Wireless Medical Telemetry - Electromagnetic Interference Concerns and Solutions [24732]
FDA Guidance for Industry - 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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