Regulatory & Quality

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Predicting Shelf Life from Accelerated Aging Data: The D&A and Variable Q10 Techniques

Predicting Shelf Life from Accelerated Aging Data: The D&A and Variable Q10 Techniques Predicting Shelf Life from Accelerated Aging Data: The D&A and Variable Q10 Techniques

The medical device industry has long been interested in techniques for predicting the shelf life of polymer-based devices. This year, that interest will increase substantially. As of June 14, 1998, the European Union is banning the sale of sterile or degradable medical devices that have no expiration dates.

Jun 1, 1998

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1 Min Read

Implementation of the FDA Modernization Act of 1997

Regulatory & Quality

Implementation of the FDA Modernization Act of 1997 Implementation of the FDA Modernization Act of 1997

Jun 1, 1998

1 Min Read

Industry Seeks to Stop FDA Budget Cuts

Regulatory & Quality

Industry Seeks to Stop FDA Budget Cuts Industry Seeks to Stop FDA Budget Cuts

byJames G. Dickinson

Jun 1, 1998

1 Min Read

Changing Diagnostic Approaches to Disease: The promise of Genetic Testing

Changing Diagnostic Approaches to Disease: The promise of Genetic Testing Changing Diagnostic Approaches to Disease: The promise of Genetic Testing

May 1, 1998

1 Min Read

Testing Medical Devices for Year 2000 Compliance

Testing Medical Devices for Year 2000 Compliance Testing Medical Devices for Year 2000 Compliance

May 1, 1998

1 Min Read

The Bug Stops Here: Stricter Environmental Controls Needed

Medical Device Regulations

The Bug Stops Here: Stricter Environmental Controls Needed The Bug Stops Here: Stricter Environmental Controls Needed

May 1, 1998

1 Min Read

A Practical Guide to ISO 10993-5: Cytotoxicity

A Practical Guide to ISO 10993-5: Cytotoxicity

byRichard F. Wallin

Quality improvement

Design & Engineering

7 Basic Tools That Can Improve Quality

7 Basic Tools That Can Improve Quality

byAshweni Sahni

Regulatory & Quality

FDA's Newest Guidance Document: When the Label Doesn't Fit

FDA's Newest Guidance Document: When the Label Doesn't Fit

byStacey L. Bell

Equipment News: Testing and inspection

Equipment News: Testing and inspection

Regulatory & Quality

The FDA Modernization Act of 1997: Part II

The FDA Modernization Act of 1997: Part II

Medical Device Regulations

Protecting Devices from Radio-Frequency Transmitters

Protecting Devices from Radio-Frequency Transmitters

Regulatory & Quality

FDA Faces the Budget Ax

FDA Faces the Budget Ax

byJames G. Dickinson

How to Meet the New Simulation Testing Requirements

How to Meet the New Simulation Testing Requirements

Regulatory & Quality

The FDA Modernization Act of 1997: Part I

The FDA Modernization Act of 1997: Part I

Regulatory & Quality

Standards and Methods for Using EtO

Standards and Methods for Using EtO

Regulatory & Quality

FDA Reforms Are Rolling, so It's Time to Focus on Going Global

FDA Reforms Are Rolling, so It's Time to Focus on Going Global

Regulatory & Quality

Tighter FDA Budget May Mean Fewer, Shorter Inspections

Tighter FDA Budget May Mean Fewer, Shorter Inspections

byJames G. Dickinson

Regulatory & Quality

Device Industry Wins Big in FDA Reform

Device Industry Wins Big in FDA Reform

byJames G. Dickinson

Regulatory & Quality

Lessons Learned, New Challenges: Life after FDA Reform

Lessons Learned, New Challenges: Life after FDA Reform

Regulatory & Quality

A Practical Guide to ISO 10993: Part 1Introduction to the Standards

A Practical Guide to ISO 10993: Part 1Introduction to the Standards

byRichard F. Wallin

Regulatory & Quality

The FDA Modernization Act: STAYING A NEW COURSE

The FDA Modernization Act: STAYING A NEW COURSE

byStacey L. Bell

Electrical Testing and Environmental Screening of Hybrid Microelectronic Devices

Electrical Testing and Environmental Screening of Hybrid Microelectronic Devices

Regulatory & Quality

Rare Harmony Marks FDA Reform Bills on Hill

Rare Harmony Marks FDA Reform Bills on Hill

byJames G. Dickinson

Regulatory & Quality

Device Companies Explore the Competitive Advantages Of Regulation

Device Companies Explore the Competitive Advantages Of Regulation

Regulatory & Quality

Displaying Investigational and Unapproved Medical Devices According to FDA Policy

Displaying Investigational and Unapproved Medical Devices According to FDA Policy

Regulatory & Quality

Draft Revision of FDA's Medical Device Software Policy Raises Warning Flags

Draft Revision of FDA's Medical Device Software Policy Raises Warning Flags

Regulatory & Quality

Industry and FDA Spar Over Labeling

Industry and FDA Spar Over Labeling

byJames G. Dickinson

Regulatory & Quality

Industry Responds to Pyronema domesticum: HIMA Screening Studies

Industry Responds to Pyronema domesticum: HIMA Screening Studies

Regulatory & Quality

The New FDA Regulation on Reports of Corrections and Removals

The New FDA Regulation on Reports of Corrections and Removals

Using Statistical Analysis in Device Testing

Using Statistical Analysis in Device Testing

EMI Testing in Medical Electronics

EMI Testing in Medical Electronics

byWilliam D. Kimmel, Daryl D. Gerke

Medical Device Regulations

Canada's Medical Device Industry Faces Cost Pressures, Regulatory Reform

Canada's Medical Device Industry Faces Cost Pressures, Regulatory Reform

Medical Packaging Validation: Complying with the Quality System Regulation and ISO 11607

Medical Packaging Validation: Complying with the Quality System Regulation and ISO 11607

Regulatory & Quality

FDA Confronts Mutual Recognition Reality

FDA Confronts Mutual Recognition Reality

byJames G. Dickinson

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