device life spanbfor estimated all medical equipment’s

Medical Device Design and Development
Medical device Design and
Development

Product Life-Cycle
• Market research
• Research
• Development
• Manufacturing engineering
• Manufacturing
• Distribution (sales & service)
• Product obsolescence and
disposal

FDA Design Controls
US regulatory requirement for
Design Controls is found in 21
CFR 820.30:
Code of Federal Regulations (CFR)
Title 21
Part 820
Section 30
Design Controls

“All manufacturers (including
specification developers) of
Class II and III devices and
select Class I devices are
required to follow DESIGN
CONTROLS [§820.30] during the
development of their device.”
21 CFR 820.30

21 CFR 820.30
“The DESIGN CONTROL requirements
are basic controls needed to ensure
that the device being designed will
perform as intended when produced
for commercial distribution.”

Design Control: Definitions
Product Result of a Process
Specification Document stating Requirements
Product
Specification
Document stating Requirements that
results from Design and
Development Control process
Design and
Development
Set of processes that transforms
Requirements into the Specification
of a Product

21 CFR 820.30 Design Control Steps
• Design and Development Planning
• Design Input
• Design Output
• Design Review
• Design Verification
• Design Validation
• Design Transfer
• Design Changes
• Design History File

“Waterfall” Design Process

Overview of Design Control
9
Planning
Determine
Customer
Requirements
D/D Planning
Start of
DC Process
Design
Planning
Design
Review
Design
Verification
Outputs: Approved Product Specification,
DHF, DMR, Batch record defined, Metrics,
Documents, Records
Design
Input
Design
Validation
Design
Changes

Two Feedback Loops
Verification loop from Design
Output to Design Input
Validation loop that
demonstrates that the medical
device satisfies user needs

Feedback
In practice, feedback operates at
all levels.
A change found necessary later in
the process will have effects that
ripple both backwards and
forwards.
• Ripple Effects Analysis
• Regression Analysis

Verification and Validation
Design Verification – Evidence
that the manufacturer made the
product right
Design Validation – Evidence
that the manufacturer made the
right product

Design Reviews
Design reviews are held at pre-
defined points during the
development process.
Additional reviews will be held on
an as-needed basis.

EU Medical Device Directives
Medical devices for sale in Europe
are regulated by “device
directives”
• Medical Device Directive (MDD
93/42/EEC)
• Active Implantable Medical Device
Directive (AIMDD 90/385/EEC)
• In Vitro Diagnostic Directive (IVDD
98/79/EEC).

EU Medical Device Directives
Each directive includes a list of
“Essential Requirements” (ERs)
that must be satisfied before a
device can be brought to market.
One method of demonstrating
conformity with the ERs is to use
“Harmonized Standards”, which give
the presumption of conformity with
the ERs.

EU Harmonized Standards
Medical Devices
http://ec.europa.eu/enterprise/newapproach/
standardization/harmstds/reflist/meddevic.ht
ml
Active Implantables
http://ec.europa.eu/enterprise/newapproach/
standardization/harmstds/reflist/implmedd.ht
ml

EU Harmonized Standards
Examples:
ISO 13485 (QMS)
EN 980 (Labelling)
EN 10993 (Biological compatibility)
EN 11607 (Packaging)
EN 14155 (Clinical Evaluation)
ISO 14971(Risk management)
EN 60601 (Medical electrical equipment)
See www.bsiamericas.com for a complete listing

QMS Standard ISO 13485
ISO 13485:2003 Medical devices
— Quality management systems
— Requirements for regulatory
purposes
ISO 13485:1996 Section 4.4
Design Controls. Intent very
similar to that of 21 CFR 820.30

ISO13485 & 21 CFR 820.30
Design Control Guidance for
Medical Device Manufacturers
(March 11, 1997)
“This Guidance relates to FDA
21 CFR 820.30 and Sub-
clause 4.4 of ISO 9001”.
NOTE: ISO 13485:1996 was the medical
device version of ISO 9001:1994 to which
the guidance refers.

Correspondence 1996 & 2003
1996 2003
1 Contract review 4.3.2, 4.4.4 7.2.1
2 D & D planning 4.4.2, 4.4.3 7.3.1
3 D & D inputs 4.4.4 7.2.1, 7.3.2
4 D & D outputs 4.4.5 7.3.3
5 D & D review 4.4.6 7.3.4
6 D & D verification 4.4.7 7.3.5
7 D & D validation 4.4.8 7.3.6
8 Control of D & D
changes
4.4.9 7.3.7

Design Controls Comparison
D&D Planning
Design Input
Design Output
Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design History File
D & D planning
D & D inputs
D & D outputs
D & D review
D & D verification
D & D validation
D & D changes

Design Dossier/ Technical File
ISO 13485:2003 does not use the
phrase “design history file”.
However, Section 4.2.1 (f) states:
“For each type or model of medical
device, the organization shall
establish and maintain a file either
containing or identifying documents
defining product specifications and
quality management requirements.”

Design Dossier/ Technical File
“These documents shall define the
complete manufacturing process
and, if applicable, installation and
servicing.”
NB-MED/2.5.1/Rec5 provides a good overall
model for technical documentation

Risk Management
ISO 13485:2003
Section 7.1, Planning for Product Realization
requires that the manufacturer “establish
documented requirements for risk
management throughout product
realization”
Section 7.3.2, Design and Development
Inputs requires that one of the inputs be the
output of risk management.
21 CFR 820.30
Risk analysis is mentioned in in the Design
Validation step.

Outputs From Design Control
Design Control Outputs:
• Design History File, Design Master Record,
Manufacturing information
• Batch record definition
• Feedback from the process
• Decisions on Outsourcing
• Post Market Surveillance on the particular
product
• Metrics on performance of the process

Planning Product Realization
• The first step once a project has been
agreed is to plan the product realization.
This occurs before Design Control
starts
• Planning should take as its input;
resource requirements known; overview
of the intended project [many times this
will take the form of marketing data,
competitive data, research information,
or other sources which the organization
wishes to pursue]; regulatory
information

• Planning includes consideration of any new
processes needed for Product Realization. This
could include production processes, as well as
design control processes
• In planning, the following should be considered:
– Quality objectives and requirements
for product
– Process and resource needs
– Verification, validation, monitoring, inspection and
test activities, criteria for product acceptance
– Records needed

• Risk Management shall have
documented requirements established
‘throughout product realization’….In
particular, this requirement does not limit
the thinking process to Design Control,
but invokes all the other requirements of
Product Realization
• Risk Management shall be documented
and records kept
• ISO 14971:2007 is recommended

Determination of
Product Requirements
The next step before Design Control is to
determine the Product Requirements,
basically the Product Specification. The
organization shall determine:
• Requirements specified by the customer
• Requirements not stated by the customer
but necessary for intended use
• Statutory and regulatory requirements…
for the product

Design and Development
The organization shall establish
documented procedures…to plan and
control the design of the product:
•Determine stages
•Design review, verification, validation and
design transfer appropriate at each stage
•Responsibilities and authorities
•Planning output is a record, and shall
be updated

D&D Inputs
• Functional, safety and performance
requirements, according to intended use
• Regulatory requirements
• Post Marketing Surveillance (PMS) data, if
available
• Risk management outputs are inputs to
this stage
• The design input record must be
documented and Approved

D&D Outputs
• Design Outputs must provide
objective evidence the design inputs
have been met
• Design outputs shall:
–be approved prior to release
–Provide information for purchasing
and production
–Contain product acceptance
criteria [production V&V]

D&D Outputs
Design Outputs can include:
• Specifications for raw materials,
component parts
• Drawings and parts lists
• Customer training materials
• Process and materials specs

D&D Outputs
• Finished medical devices specs
• Product and process software
• Quality assurance procedures
• Manufacturing and inspection procedures
• Work environment requirements
• Packaging and labeling specifications
• Identification and traceability
requirements
• Regulatory authority submissions

D&D Review
• ‘At suitable stages’ – defined in Plan
• ‘systematic reviews’
• ‘participants...shall be those…
concerned…with the stage’
• Key focus; the PRODUCT
• Key question; have we addressed all
the REQUIREMENTS

D&D Review
• Design Reviews shall be conducted in
accordance with the Design Plan
• Participants shall be competent to
evaluate the stage [s] under review
• Records….and actions…shall
be maintained:
– Purpose of review is to evaluate
ability to meet requirements and
identify problems and discuss and act
as needed

D&D Verification
• Verification shall be performed in
accordance with the Plan
• Purpose is to confirm that the Design
Outputs [which have been
documented and approved] have met
the Design Inputs [which have been
documented and approved]

D&D Verification
• Verification can include:
–Alternative calculations
–Comparing a new specification with
proven spec
–Undertaking tests
–Reviewing documents prior to issue
• Records….and actions…shall be
maintained

D&D Validation
• Validation shall be performed in
accordance with the Plan
• Purpose is to confirm that the Product
is capable of meeting the requirements
for:
– The specified application
– The intended use

D&D Validation
• Validation shall be completed prior to
delivery of the product
• Validation could include:
– Clinical evaluations required by
regulations
– Real or simulated use conditions
[completed device]
be maintained

Control of Change
• Design and development changes shall
be identified and records maintained
• Changes shall be approved
before implementation
• Changes shall consider evaluation of
impact on product already delivered
be maintained

References
1 Code of Federal Regulations (CFR) Title
21, Part 820, Section 30 (21 CFR 820.30)
Design Controls
2 ISO 13485:2003 Medical devices —
Quality management systems —
Requirements for regulatory purposes
3 ISO/TR 14969:2004 Medical devices —
Quality management systems — Guidance
on the application of ISO 13485:2003

References
4 Global Harmonization Task Force
GHTF.SG3.N99-9 Design Control
Guidance for Medical Device
Manufacturers (June 29, 1999).
Note 1: This document was archived on June 21,
2005 from the GHTF website because it is no
longer the most current information available.
ISO/TR 14969:2004, in which GHTF SG#3
participated, is considered to be the most current
guidance.
Note 2: This document contains the same basic
information as Reference 5.

References
5 Design Control Guidance for Medical
Device Manufacturers relating to FDA 21
CFR 820.30 and Sub-clause 4.4 of ISO
9001 (March 11, 1997)
6 ISO 13485:1996 Quality Systems -
Medical devices — Particular
requirements for the application of ISO
9001
7 GHTF web-site: www.GHTF.org
8 FDA CDRH web-site: www.fda.gov/cdrh

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