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.
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Hot Topics: Industry: Health Care
Professional Guides: Industry Guides
AdvaMed - Advanced Medical Technology Association [26980]
Represent manufacturers of medical devices
Represent manufacturers of medical devices
Association for the Advancement of Medical Instrumentation [16457]
Create medical instrumentation standards
Create medical instrumentation standards
FDA guidance on the basic regulatory requirements that all manufacturers and importers must consider
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
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
Procedures options for U.S. firms to export both approved and unapproved medical devices
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) Final Rule
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
Information for Manufacturers and Distributors on medical device labeling, etc.
Primer to improve the safety of medical devices by reducing likelihood of user error
Papers that discuss human factors and 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)
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
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
Federal Register notices, fees, forms, guidance documents, reports
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
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
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
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