Use of Chemical Characterization to Assess the Equivalency of Medical Devices and Materials

Use of Chemical Characterization to Assess the Equivalency of Medical Devices and Materials

Darin R. Kent, Ph.D., DABT

Medical Research Toxicologist

NAMSA

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Overview What is chemical characterization? Why is it important to characterize materials and

medical devices? Change control and material equivalency

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What is Characterization?

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What is Characterization?

A process that describes the nature of materials used in medical devices

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What is Characterization?

The process is a series of tests that delineates the properties of the material

Chemical Toxicological Physical Mechanical Morphological Electrical

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Why Characterize Materials and Medical Devices?

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Why Characterize Materials and Medical Devices?

Safety As part of an assessment of the overall biological safety

of a medical device (EN ISO 10993-1 and 14971)

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Why Characterize Materials and Medical Devices?

Safety As part of an assessment of the overall biological safety

of a medical device (EN ISO 10993-1 and 14971) Performance

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Why Characterize Materials and Medical Devices?

Safety As part of an assessment of the overall biological safety

of a medical device (EN ISO 10993-1 and 14971) Performance Problem Solving (change control and material equivalency)

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Why Characterize Materials and Medical Devices?

Safety As part of an assessment of the overall biological safety

of a medical device (EN ISO 10993-1 and 14971) Performance Problem Solving (change control and material equivalency) Regulatory (Compliance with FDA, Notified Bodies and ISO

Standards)

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Why Characterize Materials and Medical Devices?

Establishes baseline testing that will serve as a benchmark

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Why Characterize Materials and Medical Devices?

Establishes baseline testing that will serve as a benchmark Baseline testing serves as a standard by which other

materials may be measure or judged

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Why Characterize Materials and Medical Devices?

Establishes baseline testing that will serve as a benchmark Baseline testing serves as a standard by which other

materials may be measure or judged Standard tests used to compare the quality and

performance of future materials or processes

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Why Characterize Materials and Medical Devices?

Materials characterization is a dynamic ongoing process to be used throughout the lifetime of a medical device

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Why Characterize Materials and Medical Devices?

Materials characterization is a dynamic ongoing process to be used throughout the lifetime of a medical device

Materials characterization helps monitor material quality, manufacturing processes and sterilization procedures

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Why Characterize Materials and Medical Devices?

Materials characterization is a dynamic ongoing process to be used throughout the lifetime of a medical device

Materials characterization helps monitor material quality, manufacturing processes and sterilization procedures

When used properly, will eliminate the need to repeat expensive and time consuming biological testing to qualify new lots or vendors

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Change Control and Material Equivalency

What is Change Control?

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Change Control and Material Equivalency

What is Change Control? The processes and procedures to manage changes being

made to a product

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Change Control and Material Equivalency

What is Change Control? The processes and procedures to manage changes being

made to a product The review, approval/disapproval, implementation, tracking,

closure and status reporting of proposed changes to an item

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Change Control and Material Equivalency

ISO 10993-18

Biological Evaluation of Medical Devices, Part 18: Chemical Characterization of Materials

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Change Control and Material Equivalency

ISO 10993-18

Biological Evaluation of Medical Devices, Part 18: Chemical Characterization of Materials Used to judge equivalency of proposed material to a

clinically established material

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Change Control and Material Equivalency

ISO 10993-18

Biological Evaluation of Medical Devices, Part 18: Chemical Characterization of Materials Used to judge equivalency of proposed material to a

clinically established material Also used to judge equivalency of a prototype device to a

final device

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To view the complete series about the Use of Chemical Characterization to Assess the Equivalency of Medical Devices and Materials Visit NAMSA Seminars

For information about the services NAMSA can offer you regarding chemical characterization Check out our

Materials Characterization and Analytical Chemistry page For additional information

Download our brochure on Material Characterization and Analytical Chemistry

Read Using Chemical Characterization to Show Equivalency written by David Albert & Amy Hoffmann published in MD&DI

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