White Paper Design History Files Design Control Documentation

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Design History Files – Design Control Documentation

Your organization has identified a new product idea for a medical device. What’s next?

This White Paper focuses on Design Control compliance for Medical Devices per 21 CFR

820.30 and ISO 13485: 2016 § 7.3, including Design History File documentation.

What is a Design History File (DHF)?

The DHF is a compilation of records which describes the design history of a finished

device. It includes or references records generated to demonstrate conformity to the

requirements for design and development, as well as records for design and development

changes. The DHF documents device development in accordance with the approved

Design Plan.

ISO 13485 and 21 CFR 820.30 require that Design and Development Files / Design History

Files (DHF) be established and maintained for each medical device type (or family).

Phases

DHFs can be broken down into phases, to appropriately document design and

development activities per each design phase.

1. Design and Development Planning

2. Design and Development Inputs

3. Design and Development Outputs

4. Design and Development Review

5. Design and Development Verification

6. Design and Development Validation

7. Design and Development Transfer

8. Control of Design and Development Changes

Each of these phases is further described below.

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Design and Development Planning

The purpose of the Design and Development Plan is to describe the design and

development activities, as well as define the responsibilities for their implementation.

What interfaces will be required between departments?

What activities will provide an input to the Design and Development Process?

The Design and Development Plan provides a mechanism for documenting:

• Design and development stages (including schedule, where appropriate);

• Reviews needed at each stage;

• Verification, Validation and Design Transfer activities that are appropriate at each

stage;

• Responsibilities and Authorities;

• Methods to ensure traceability of Outputs to Inputs;

• Resources Needed, including necessary competence of personnel

The Design and Development Plan requires review, updates (where appropriate) and

approval as the design and development evolves.

Design and Development Inputs

Design Inputs are the physical and performance requirements of a device used as a basis

for device design.

Device requirements defined within the Design Inputs must be appropriate to address the

intended use of the device, including the needs of the user and patient. The Design Input

requirements cannot be incomplete, ambiguous or conflicting. They must be documented,

reviewed and approved (signature and date) by a designated individual and maintained.

Design Inputs include:

• Functional, performance, usability and safety requirements, according to the

intended use;

• Applicable regulatory requirements and standards;

• Applicable Outputs of Risk Management;

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• Information derived from previous similar designs (as appropriate);

• Other requirements essential for design and development of the product and

processes.

Example requirements from product concepts include drawings, product briefs,

specifications, etc.

Design and Development Outputs

Design Outputs are the results of design effort at each design phase and at the end of the

total design effort. The finished Design Output is the basis for the Device Master Record.

The total finished Design Output consists of the device, its packaging and labeling, and the

Device Master Record.

Design Outputs evaluate the conformance to Design Input requirements. Design Output

procedures contain or reference acceptance criteria and ensure Design Outputs are

essential for the proper functioning of the device are identified. Design Outputs must be

documented, reviewed and approved (signature and date) before release and records

maintained.

Design Outputs:

• Meet the input requirements for design and development;

• Provide appropriate information for purchasing, production and service provision (as

appropriate);

• Contain or reference product acceptance criteria;

• Specify the characteristics of the product that are essential for it’s safe and proper

use.

The Design Outputs shall be in a form suitable for verification against the Design Inputs.

This can be achieved through the use of an appropriate Design Input / Output Table and /

or Traceability (Trace) Matrix. Other suitable formats may also be utilized.

Example Design Outputs include purchasing specifications, process specifications, test

results, etc.

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Design and Development Review

Design Reviews are a documented, comprehensive, systematic examination of a design to

evaluate the adequacy of the design requirements, to evaluate the capability of the design

to meet these requirements, and to identify problems.

Formal, documented Design Reviews are required at appropriate stages of the device’s

design development. This may be according to Design Control procedures, or as defined

in the Design Plan, as applicable. The intent of the Design Review is to evaluate Design

and Development Results obtained and evaluate their ability to meet requirements. Where

appropriate, this also serves as a forum to identify and propose necessary actions for

improvement to these activities.

Design Review participants must represent all functions concerned with the design stage

being reviewed, along with an independent reviewer and any specialists needed. Results

of the Design Review, including identification of the design, date and participants shall be

documented in the DHF.

Design and Development Verification

Verification is confirmation by examination and provision of objective evidence that

specified requirements have been fulfilled.

Manufacturers must establish and maintain procedures to verify the device design. The

intent is to confirm that the Design Outputs meet the Design Input requirements.

Verification Plans must identify methods, acceptance criteria and statistical techniques, as

appropriate. This can be conducted within the Trace Matrix in a format suitable to record

verification activities.

Where the device Intended Use requires that the medical device be connected to, or

interface with other medical devices, verification activities must review the device when so

connected / interfaced, as required.

Documentation must include results and conclusions of the Design Verification, including

details such as identification of the design, methods, necessary actions, date and

individuals performing the verification.

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A general example format is provided below:

Design Input

Reference

Design Input

requirement

Design Output

Reference

Design Verification

Reference

Reference the

applicable Design

Input document

Describe the

Design Input

requirement.

Reference the

Design Output(s)

that fulfill the

Design Input

requirement

Reference the

applicable Design

Output /

Verification

document.

Design and Development Validation

Design validation establishes by objective evidence that device specifications conform with

user needs and intended use(s).

Manufacturers must establish and maintain procedures to validate the device design. This

must take place under defined operating conditions, on production equivalent product. This

is intended to ensure that devices conform to defined user needs, application and intended

uses and shall include testing of production equivalent units under actual or simulated use

conditions. Design Validation Plans must identify methods, acceptance criteria and

statistical techniques, as appropriate.

Design Validation shall include software validation and risk analysis, as appropriate. It is

also appropriate to perform Clinical Evaluations or performance evaluations of the device in

this phase.

Where the device Intended Use requires that the medical device be connected to, or

interface with other medical devices, validation activities must review the device when so

connected / interfaced, as required.

Documentation must include results of the Design Validation, including identification of the

design, methods, dated and individuals performing the validation.

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Design and Development Transfer

Design Transfer allows for the device transfer from design to manufacturing.

Manufacturers must establish and maintain procedures to translate device design into

production specifications. This includes the transfer of Design Outputs to Manufacturing.

Procedures established shall ensure that Design Outputs are verified as suitable for

manufacturing before becoming final production specifications and that production

capability can meet product requirements.

One suggestion is to take manufacturing procedures developed during design and test

them under pilot conditions. This allows for the identification of any potential manufacturing

challenges, prior to launching full manufacturing operations.

Design and Development Changes

Manufacturers must establish and maintain procedures for the identification,

documentation, validation or where appropriate, verification, review and approval of design

changes before their implementation. This is intended to control design and development

changes. Through this process, the organization shall determine the significance of the

changes to function, performance, usability, safety and applicable regulatory requirements

for the device and its intended use. The Design Change review shall include evaluation of

the effect of the changes on constituent parts and product in process or already delivered,

inputs or outputs of risk management and product realization processes.

One thing to note, Design Change is relevant to devices in development. Once the product

is launched and Transfer has taken place, the Device Master Record (including Change

Control activities) become the forum for managing changes. Where appropriate; however,

design changes may drive the initiation of further Design Control activities.

Design and Development Files – Design History File

A DHF shall be maintained for each type of device / device family. It shall contain or

reference the records necessary to demonstrate that the design was developed in

accordance with the approved Design Plan, and records for Design Changes.

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The phases and documents discussed above, represent appropriate content for including /

referencing within the respective DHF.

Summary

A DHF is compilation of records describing the design history of a finished device.

Development occurs according to an approved Design Plan and records generated are

included or referenced within the DHF. Records include, but are not limited to the Design

Plan, Design Inputs, Design Outputs, Design Reviews, Design Verification, Design

Validation

ABOUT THE AUTHOR: Nola Benstog is a diversified professional with a thorough knowledge of Quality Management Systems.

She has over sixteen years of experience in the areas of Quality Assurance, Quality Control, Regulatory Affairs, Validation and

Sterilization in both industry and consulting roles. She has worked in the medical device, pharmaceutical, combination product and

nutritional supplement industries with experience ranging from start- ups to Fortune 100 and 500 companies. She began her career as

a Technician in a Microbiology Lab and has held various positions up to the Executive Management level throughout her career.

Nola received a Bachelor of Science in Microbiology from Weber State University and a Master of Business Administration from Utah

State University. She has been an American Society for Quality (ASQ) Certified Quality Auditor (CQA) since 2007.