3/23/2020

Dr. Fayez Abou Hamad

MDV-Solve
Purpose of the course
❑ The session describes how to establish and implement a
system for design controls for various classes of medical
devices for both the U.S. and Europe.
❑ Practical exercises will be used to ensure good
understanding.
❑ Procedures and forms will be explained

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Design Control – Reference

❑EN ISO 13485 –

Chapter 7.3: Design and development

❑(QSR) 21 CFR part 820 –

Section 820.30: Design controls

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Design Control – Historic Overview
❑ 1990: An FDA study title "Device Recalls: A Study of Quality Problems,"
published in May, 1990, contained reports that approximately 44%of the
quality problems that led to voluntary recall actions during the six years
from1983 to1989 were attributable to errors or deficiencies that might
have been prevented by mandated design controls.

❑ 1990: Congress Responds with Legislation. The Safe Medical Device Act
(SMDA) of 1990 gave the FDA the power to implement the Preproduction
Quality Assurance program that required medical device manufacturers
to address problems in product design which contribute to malfunctions.

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Design Control – Historic Overview

❑ 1992: the Office of Device Evaluation (ODE) has required device

manufacturers to demonstrate safety and efficacy with various tests including
biocompatibility, electrical safety, and , in may cases, clinical testing

❑ 1995: FDA drafts guidance for medical device manufacture

❑ 1997: FDA cGMPs regulation effective and FDA inspecting design control
compliance
❑ 1997: Medical Device Directive includes design controls

❑ 2003: ISO13485 adopted by EU and Canada – design control

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Design Control – Basic Definition

❑ Design controls are a component of a quality system that covers the life cycle
of a device to ensure that specified design requirements are met and the
device will reach an acceptable level of efficacy and safety.
❑ Design control begins with development and approval of device design inputs,
includes the design activities and the associated manufacturing processes.
❑ Design control applies to all changes to the device or manufacturing process
design, including those occurring long after a device has been introduced to the
market.
❑ Formal design control is not required for feasibility studies. Once it is decided
that a design concept is feasible and will be developed, design control then
applicable.

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Design Control – General Requirements

Each manufacturer shall establish and

maintain procedures to control the
design of a device in order to ensure
that specified design requirements are
met.

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Design Control – Basic Elements Part 820

 Design Planning & Development Design Input

 Design Output
 Design Verification
 Design Review
 Design Validation
 Design Changes
 Design Transfer

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Design Control – Basic Elements - ISO

 Design and Development Planning

 Design and Development Inputs
 Design and Development Outputs
 Design and Development Review
 Design and Development Verification
 Design and Development Validation
 Design and Development Transfer
 Control of Design and Development Changes

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Design and Development – EN ISO 13485:2016
7.3.1 General
The organization shall document procedures for design and development.
7.3.2 Design and development planning
The organization shall plan and control the design and development of product. As
appropriate, design and development planning documents shall be maintained and
updated as the design and development progresses.
During design and development planning, the organization shall document:
a) the design and development stages;
b) the review(s) needed at each design and development stage;
c) the verification, validation, and design transfer activities that are appropriate at
each design and development stage;
d) the responsibilities and authorities for design and development;
e) the methods to ensure traceability of design and development outputs to design
and development inputs;
f) the resources needed, including necessary competence of personnel.

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Design and Development – EN ISO 13485:2016
7.3.3 Design and development inputs
Inputs relating to product requirements shall be determined and records maintained.
These inputs shall include:
a) functional, performance, usability and safety requirements, according to the
intended use;
b) applicable regulatory requirements and standards;
c) applicable output(s) of risk management;
d) as appropriate, information derived from previous similar designs;
e) other requirements essential for design and development of the product and
processes.
These inputs shall be reviewed for adequacy and approved.
Requirements shall be complete, unambiguous, able to be verified or validated, and
not in conflict with each other.
NOTE Further information can be found in IEC 62366–1.

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Design and Development – EN ISO 13485:2016
7.3.4 Design and development outputs
Design and development outputs shall:
a) meet the input requirements for design and development;
b) provide appropriate information for purchasing, production and service provision;
c) contain or reference product acceptance criteria;
d) specify the characteristics of the product that are essential for its safe and proper
use.
The outputs of design and development shall be in a form suitable for verification
against the design and development inputs and shall be approved prior to release.
Records of the design and development outputs shall be maintained (see 4.2.5).

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Design and Development – EN ISO 13485:2016
7.3.5 Design and development review
At suitable stages, systematic reviews of design and development shall be
performed in accordance
with planned and documented arrangements to:
a) evaluate the ability of the results of design and development to meet
requirements;
b) identify and propose necessary actions.

Participants in such reviews shall include representatives of functions concerned with

the design and development stage being reviewed, as well as other specialist
personnel.
Records of the results of the reviews and any necessary actions shall be maintained
and include the identification of the design under review, the participants involved
and the date of the review.

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Design and Development – EN ISO 13485:2016

7.3.6 Design and development verification

Design and development verification shall be performed in accordance with planned
and documented arrangements to ensure that the design and development outputs
have met the design and development
input requirements.
The organization shall document verification plans that include methods, acceptance
criteria and, as appropriate, statistical techniques with rationale for sample size.
If the intended use requires that the medical device be connected to, or have an
interface with, other medical device(s), verification shall include confirmation that the
design outputs meet design inputs when so connected or interfaced.
Records of the results and conclusions of the verification and necessary actions shall
be maintained.

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Design and Development – EN ISO 13485:2016
7.3.7 Design and development validation
Design and development validation shall be performed in accordance with planned
and documented
arrangements to ensure that the resulting product is capable of meeting the
requirements for the
specified application or intended use.
The organization shall document validation plans that include methods, acceptance
criteria and, as appropriate, statistical techniques with rationale for sample size.

Design validation shall be conducted on representative product. Representative

product includes initial production units, batches or their equivalents. The rationale
for the choice of product used for validation shall be recorded.

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Design and Development – EN ISO 13485:2016
7.3.7 Design and development validation
As part of design and development validation, the organization shall perform clinical
evaluations or performance evaluations of the medical device in accordance with
applicable regulatory requirements.
A medical device used for clinical evaluation or performance evaluation is not
considered to be released for use to the customer.
If the intended use requires that the medical device be connected to, or have an
interface with, other medical device(s), validation shall include confirmation that the
requirements for the specified application or intended use have been met when so
connected or interfaced.
Validation shall be completed prior to release for use of the product to the customer.
Records of the results and conclusion of validation and necessary actions shall be
maintained.

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Design and Development – EN ISO 13485:2016
7.3.8 Design and development transfer
The organization shall document procedures for transfer of design and development
outputs to manufacturing. These procedures shall ensure that design and
development outputs are verified
as suitable for manufacturing before becoming final production specifications and
that production capability can meet product requirements.

Results and conclusions of the transfer shall be recorded.

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Design and Development – EN ISO 13485:2016
7.3.9 Control of design and development changes
The organization shall document procedures to control design and development
changes. The organization shall determine the significance of the change to function,
performance, usability, safety and applicable regulatory requirements for the
medical device and its intended use.
Design and development changes shall be identified. Before implementation, the
changes shall be: a) reviewed; b) verified; c) validated, as appropriate; d) approved.
The review of design and development changes 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.
Records of changes, their review and any necessary actions shall be maintained.

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Design and Development – EN ISO 13485:2016
7.3.10 Design and development files
The organization shall maintain a design and development file for each medical
device type or medical device family. This file shall include or reference records
generated to demonstrate conformity to the requirements for design and
development and records for design and development changes.

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Application of Design Control
Design change

User Review
needs

Design
Input

Design
process

Design
Verification
output
Medical
Validation Device
Design Transfer

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Application of Design Control

MDV-Solve 21
Design and Development Planning
❑ Is needed to ensure that the design process is appropriately controlled and
that device quality objectives are met.
❑ Describe design and development activities.
❑ Identification of the major tasks to be undertaken (during input, output,
verification, validating, transfer phases), deliverables for each task, and
individual or organizational responsibilities (staff and resources) for
completing each task.
❑ Scheduling of major tasks to meet overall program time constraints.
Identification of major reviews and decision points.
❑ Identify and describe interfaces between different groups or activities.
❑ Review, update, and approve plans as design and development evolves.

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Design and Development Planning

Project plan - Tools

✓Project Team members

✓Project Design Planning Checklist

✓High Level Planning

✓Development Plan Status

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Design Input
❑ Ensure requirements are appropriate and address intended use of device.
✓ Physical characteristics (materials, size, weight, shape, colour)

✓ Functional performance characteristics (for testing)

✓ Chemical and Biocompatibility requirements

✓ Usability of the device

❑ Regulatory requirements (applicable standards, registration, Labelling)

❑ Address incomplete, ambiguous, or conflicting requirements.
❑ Document, review, and approve input requirements.

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Design Input
❑ Input requirements from all previous assessments should translated in
specifications (measurable) sheet to be reviewed and approved = change
control
❑ Design input is the starting point for product design. Therefore,
development of a solid foundation of requirements and specifications is
the single most important design control activity.

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Design Output
❑ When the design input has been Approved, The first step is conversion of
the requirements into system or high-level specifications. Thus, these
specifications are a design output. Upon verification that the high-level
specifications conform to the design input requirements, they become
the design input for the next step in the design process, and so on.
❑ This basic technique is used repeatedly throughout the design process.
Each design input is converted into a new design output; each output is
verified as conforming to its input; and it then becomes the design input
for another step in the design process.

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Design Output
❑ Define and document design output in terms that allow evaluation to design
input.

❑ Reference acceptance criteria.

❑ Identify design outputs essential for the proper functioning of device.

❑ Document, review, and approve design outputs before release.

❑ Results of design effort at each phase and the end of the total design effort.

❑ Finished design output is basis for the Device Master record, Technical file,
510k file.

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Design Output
❑ Production specifications include drawings and documents used to
procure components, fabricate, test, inspect, install, maintain, and
service the device, such as the following:
 assembly drawings
 component and material specifications
 production and process specifications
 work instructions
 quality assurance specifications and procedures
 installation and servicing procedures
 packaging and labelling specifications, including methods and processes
used

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Design Review
❑ A documented, comprehensive, systematic
examination to
 Provide a systematic assessment of design results
 Evaluate capability of the design to meet requirements
 Provide feedback on existing or emerging problems;
 Assess project progress; and/or provide confirmation
that the project is ready to move on to the next stage of
development.

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Design Review

 Conducted at appropriate stages of the device's design

development.
 Includes representatives of all functions involved with the
design stage being reviewed.
 Includes any specialist needed & an independent reviewers.
 Recap prior reviews.
 Approval of “Design changes”.
 Documented. (results, participants, date, action lists,
responsibilities).
 Part of the Design History File.

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Design Review
Preliminary Design Review:
 The objective is to review several design concepts for acceptability and
feasibility relative to design function. The review is documented in the Design
History File (DHF).
Interim Design Review:
 These reviews conducted to assure conformance to project requirements and
identify potential problems. The Project Leader and Team determine the extent,
frequency and personnel required for these reviews, which are then documented
in the DHF.
Final Design Review:
 Conducted to assure that the design is safe, reliable and efficacious and has met
the Project Requirements. The review is approved and documented in the DHF.

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Design Verification
Design Output = Design Input
 Design Verification are continuous ongoing action
through output process
 Final design verification to be conduct on the final
product to confirm that design output meets design
input requirements
“Did we develop the product right”?
 Verification is to assure all safety performance, and
reliability requirements have been met including
product usage under simulated use conditions.
 Documented in the Design History File.

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Design Validation
 Design validation means establishing by objective evidence that
device specifications conform with user needs and intended
use(s).
“Did we develop the right product”?
 Perform on devices made under defined operating conditions
on initial production units or equivalent (process
validation).
 Test of production units under actual or simulated use
conditions (HCP on test model – mock operating room).
 Clinical evaluation (literature evaluation, clinical survey)
 Prior to product release!
 Document results in the DHF.

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Verification versus Validation
Verification =
“Did we develop the product right”?
Validation =
“Did we develop the right product”?

Simply: Verification is first step in Validation

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Design Transfer
 Transfer activities may start at certain output point.
At the end of design transfer:
 Ensure that production process is validated
 Design validation may be a part of the transfer process (= product
from PQ run for design validation).
 Ensure the device design is correctly translated into production
specifications.
 Specifications, methods and work procedures approved to assure
they are adequate for the manufacturer to produce products that
will meet the specified requirements.
 May include training of personnel.

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Design Transfer
Design transfer documentation assurance
 Specifications (Device master records)
 BOM

 Methods (work instructions)

 Training records
 Label copies
 Drawings

 Quality inspections.

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Post Market Monitoring

 Collect information after market introduction of the

product.
 Complaints.
 Intended use remarks.
 Usability remarks.

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Design changes
 Evolutionary changes (performance enhancements)
 Revolutionary changes (corrective actions)
 Changes :
 During the design process.
 After the launch of the product.
 All changes has to go trough “Design Control”

Design changes must be reviewed and approved.

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Design History File -Design and Development File
 The Design History File (DHF) or Design and Development File
(ISO) means a compilation of records which describe the
design history of a device.
 The DHF should be reviewed for accuracy and completeness
prior to archiving.
 The DHF is considered a quality record and should be
controlled as such.

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Design History File
 Section 1:
 Design plan + input (assessments).
 Project brief (project manager + project team).
 Risk analysis.
 Overview of the design input.
 Section 2:
 Design output (testing results, drawing, …..)
 Section 3:
 Design verification (output = input)
 Design changes
 Section 4:
 Design reviews
 Process validation
 Design validation

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Design History File
 Section 5:
 Design transfer
 Specifications (Device master records)
 BOM
 Methods (work instructions)
 Training records
 Label copies
 Drawings
 Quality inspections. (In Process).

 Section 6:
 Post marketing monitoring.

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Design History File

If no DHF for existing devices

 Documented evidence of all changes

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Design Control (ISO13485-CFR 820.30)

Procedures and forms

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QUESTIONS

THANK YOU

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