Design & Safety
Safety
Medical Devices

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

A series of articles related to the subject

Articles on quality assurance and control for medical device safety

An effective quality system must integrate risk management, customer satisfaction, and continuous improvement

How to report a problem to ECRI and to the FDA

US FDA requirements for ionizing and non-ionizing products, including medical products

Applying HACCP principles can minimize the introduction of risk factors in medical device safety

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

Databases of interest to medical device manufacturers

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

Good guidance practice documents

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

Guidance, forms and fee information

HE 75 is the result of the effort to create best practices guidance in medical device human factors engineering

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

Papers that discuss human factors and medical devices

Human factors guidance from the FDA

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

A series of articles related to the subject

Federal Register notices, fees, forms, guidance documents, reports

FDA regulatory guidance on the marketing of medical gloves

Laws, regulations, industr guidance and more

Implementation of the Mammography Quality Standards Act of 1992 (MQSA) - inspections

FDA compliance guidance for mammography facilities

Manufacturers must follow certain requirements and regulations once devices are on the market

FDA Good Manufacturing Practice (GMP) Requirements Quality System (QS) Regulation Information

Guidance on FDA requirements

FDA database of medical device recalls

A series of articles on the subject

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