VERIFICATION & TESTING STRATEGIES

FOR COMPLIANCE WITH ISO

13485:2016, IEC 62304 / 60601-1 /
82304-1
AUGUST 6TH, 2020
WEBINAR
 MEDICAL DEVICE QUALITY IS ALL WE DO,
AND WE’RE ALWAYS AHEAD OF THE GAME
 Rook Quality Systems is a consulting firm dedicated to helping startup to mid-

sized medical device companies develop and maintain effective and efficient

quality systems.

Rook Quality We provide specialized and custom consulting services for all classes of

medical devices, including medical software and combination devices.

Systems

Quality System DHF/ TF Audit Support Software

Design Creation Validation

Design Control Risk Regulatory Quality System

Management Submission Training
Support (Int’l)
 KYLE ROSE, PRESIDENT
Medical Device expert specializing in development of efficient Quality Systems for small
and startup medical device companies
Works as the contract Quality Manager for multiple medical device companies

Intro to overseeing overall quality strategy and ensuring compliance through documentation
and auditing services

Kyle Rose Certified quality auditor with regulatory and audit experience for a variety of markets
including FDA, CE Mark, MDSAP, and CFDA
Serves as a quality mentor to many medical device incubators around the world
Rook Quality encourages the simplification of Quality Systems to reduce the quality
burden and improve compliance through training and efficient QS design

Greenlight Guru Verification and Validation Design Control

Post Market Surveillance & Medical Device Software

PMCF Validation

Complaint Handling Quality System Development Risk Management

ISO 13485:2016, 21 CFR 820, MDD Corrective and

and MDR, ISO 14971 Preventative Actions

Product Development Internal and Supplier Audits

 1. Overview of Medical Device Testing
2. How to Identify Testing

3. External Testing Laboratories

Webinar 4. IEC 60601 / 61010
Outline
5. Software Testing IEC 62034

6. Internal Bench Testing

7. What to do if you fail

8. Ongoing Testing / Questions

 • 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

Overview of outputs have met the design and development

• input requirements.
Medical • The organization shall document verification plans that include
methods, acceptance criteria and, as
Device • appropriate, statistical techniques with rationale for sample
size.
Testing • 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.
 • FDA 21 CFR 820.30
• Design verification
Overview of • Each manufacturer shall establish and
maintain procedures for verifying the device
Medical design. Design verification shall confirm that
the design output meets the design input
Device requirements. The results of the design
Testing verification, including identification of the
design, method(s), the date, and the
individual(s) performing the verification,
shall be documented in the DHF.
 Design Control
Design User Needs How your needs are met Design Input How your inputs are met Design Outputs
Planning Generic Needs Specifications Proof of Specification

User Needs

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Validation Clinical Evidence Bench testing

21 CFR 820.30
ISO 13485:2016 section 7.3
Overview of Medical Device Testing
Execute
Test Protocol Report
Protocol
• Designed to show
how Design Outputs
• Summarize
meet Design Inputs
testing data
• Define testing • Capture test
• Results of test
process results
• Capture any
• Define sample size
deviations
and acceptance
criteria
 • Design Traceability Matrix - Verify Inputs meet
Outputs
• Determine regulatory requirements for specific
How to device
• Identify if the regulatory testing applies to your
Identify device
Testing • Discuss with testing lab
• Confirm testing plan if unsure (pre-submission
meeting)
How to Identify Testing
Design Traceability Matrix - Verify Inputs meet Outputs

Create design If you are unsure of the

Ensure the
inputs/software specifications or tolerances
inputs/requirements can
requirements for your create testing protocols to
be tested or verified
device determine specifications
 • Regulatory Requirements
• Identify the product code for your device
• Search product code on the FDA website
and identify consensus standards.
How to • Purchase Standards – Review the
standards in detail
Identify • Review FDA website to identify any FDA
Testing Guidance documents related to your
device
• Review Predicate Devices
 • Regulatory Requirements
• Review Consensus Standards, Guidance
Docs, and Predicates to determine if the
standard applies to your device
How to • There may be situations where you can
Identify justify not doing testing using various
methods
Testing • Risk Review
• Materials/components already tested to
standard
 • Discuss with Testing Lab
• Determine if any of the testing will
require external laboratories to complete
• 60601/61010

External • FCC/Wireless Co-existence testing

• Biocompatibility

Testing • Discuss strategies and requirements of

testing with the test lab
• Confirm sample size
 • Get multiple quotes from testing labs
• Compare quotes and discuss timelines
• Confirm if possible that all testing will be
External completed at the same facility
• Determine timelines for testing and document
Testing review
• Implement testing
 • Requirement for electrical medical
devices
• Multiple components of the 60601
standard that need to be reviewed
IEC 60601 • Testing is just part of the certification
Testing • Risk Management File reviewed in detail
• IFU and Label reviewed in detail
 • Requirement for electrical medical
devices
• Multiple components of the 60601
standard that need to be reviewed
IEC 60601 • Testing is just part of the
certification
Testing • Risk Management File reviewed in
detail
• IFU and Label reviewed in detail
 • Review to see if additional
sections of the standard are
required for your device
• 60601-1-11 Home Use Device
IEC 60601 • 60601-1-3 X-Ray Systems
Testing • 60101-1,2 Electrical Lab
Equipment (Diagnostic Devices)
• 80601-2-56 Clinical Thermometer
 • Review quotes and agree to tests to
be completed
• Ship devices for testing (multiple,
IEC 60601 may be destructive)
Testing • Submit RMF, IFU, Label
• Submit documentation for device
Process components, data sheets, material
specifications, antenna
 • Complete required paperwork
to begin testing
• insulation diagram
IEC 60601 • essential performance
Testing • classification
• risk checklists
Process • Begin testing
• Review Report
Software V&V: How it fits into the
Software Lifecycle
Risk-based Requirement Create Requirement Specifications
Qualification and Definitions (URS, • User Requirement Specifications
Classification SRS, SDS) • Describe how software integrates
with clinical workflow
• Software Requirement Specifications
• Frontend
Verification and • Backend
Implementation • Risk control measures
Validation
• Non-functional
• Algorithm performance
• Data requirements
• Software design Specifications
Release and Maintenance
• Architecture design decisions based
Deployment and Update
on URS, SRS, and risks.
Software V&V: Verification Planning
v Structured such that the developed software
Risk-based Requirement
Qualification and Definitions (URS, meets the defined requirements
Classification SRS, SDS) v Verification should be considered when
requirements are being developed (high-level)

• IEC 62304 Testing

• Identify Risk Classification per IEC 62304
Verification and
Implementation • Test coverage driven by risk profile
Validation
• Unit, integration & system level
• Verification Planning
• Primary purpose to look into defects
• Defect tracking method needs to be
Release and Maintenance identified up front
Deployment and Update • Acceptance criteria clearly laid out for each
test case planned
Software V&V Execution
• Ideally, requirements should be implemented
Risk-based Requirement
Qualification and Definitions (URS, before beginning software verification
Classification SRS, SDS)
• Test Cases
• Establish entry and exit criteria to define
when test execution can begin and end
• Test Environment should be detailed to
Verification and
Implementation capture intended use scenario
Validation
• Test assumptions should outline any
preparation steps needed to produce the
expected results in the test case
• Validation
Release and Maintenance • Scenarios cover the clinical user and
Deployment and Update environment
• Acceptable failure behavior
 • Perform all identified testing on a finished device design, or an
accurate prototype of the device, not on a device that is still under
development and subject to design changes
• Determine Master Testing Plan
• Testing of your device's design outputs/specifications
• Such as: Mechanical and Bioengineering performance
Internal • Example: Fatigue, wear, tensile strength, compression, and
burst pressure; bench tests using ex vivo, in vitro, and in situ

Bench animal or human tissue; and animal carcass or human

cadaveric testing

Testing • Testing identified through Risk Assessments

• Testing per applicable device specific regulatory
standards/guidance doc
• Testing Documentation
• Test Protocols & Test Report Templates to be used during testing
• Final Test Reports & Summaries to be included in your
premarket submission
 • Define your Test Objectives (specifications or compliance to a
regulatory standard/guidance)
• Determine Sampling Parameters
• Sample: Entire device/a part or component/attribute of the device

Internal • Is it the final/finished device subjected to all manufacturing processes?

• If not, justify why this approach is appropriate given any differences that

Bench
may impact performance of the tested device
• Sample Size: Based on Test Objectives, Risk Analysis, Sampling Plan or as
described in the standard/guidance
Testing • Describe sample configuration, how samples represent a clinically
relevant scenario and how inter and intra lot variability are accounted
Elements for
• Determine Pass/Fail Criteria (when applicable)
• Should be Pre-Defined: Based on performance needs & intended use of
the device
• For characterization tests without an acceptance criteria, determine
assessment criteria
 • Determine Data Analysis Plan
• Planned Qualitative and/or Quantitative Assessments
• Test Results
• Present data collected for all samples (including outlying results) in data
sheets or tables

Internal • Accompanied by summaries, statistical information, additional images,

rounding methods

Bench
• Data Analysis
• Conclude with if acceptance criteria were met and describe potential
reasons of failure
Testing • Determine if re-testing is required, describe test protocol deviations and
assess impact on test results
• Discussion/Conclusions
• Discuss conclusions drawn from test results with respect to stated
objectives
• Whether pre-specified acceptance criteria were met
 oSummarize failure in the test report
oDetermine the root cause of the failure
oIdentify how to edit device or software for a
What to do if better result

you Fail? oCapture changes in design file (Design

Input/Output changes)
oConduct re-testing
oRepeat as necessary
 oCapture changes in design file (Design
Input/Output changes)
oUtilized design traceability matrix and
a risk assessment to determine if
Ongoing additional verification testing is needed
Design oJustify reasons for not testing
Changes and oUpdate DHF with new outputs and
Testing testing
oTrack changes in ECO, Software Change
process
oRelease new design
 www.RookQS.com
Questions?
Contact info@rookqs.com for more questions,
comments, or to set up a meeting. One of our
consultants will be sure to reach out to assist!

kyle.rose@rookqs.com