The document discusses the classification, regulation, and quality standards of medical devices as managed by the FDA. It outlines the definitions, risks associated with different device classes, and the necessary standards for effective medical device management and testing. Additionally, it emphasizes the importance of feasibility studies, documentation, and various testing techniques used in ensuring device safety and effectiveness.

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Embedded: Specific of Medical projects
Volodymyr Palamar
Engineering Manager
23 Nov 2017

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Agenda
1. Intro
2. Medical Device
3. FDA
4. Let’s get started
5. Q&A

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Intro

4. 44
Medical devices

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What is a medical device?
• A medical device is "an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article,
including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them
- intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other
animals, and which does not achieve any of its primary intended purposes
through chemical action within or on the body of man or other animals and which
is not dependent upon being metabolized for the achievement of any of its
primary intended purposes.

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Medical device classes
• Classes of devices:
- Class I (or A)
• Class I devices are deemed to be low risk and are therefore subject to the least
regulatory controls.
- Class II (or B)
• Class II devices are higher risk devices than Class I and require greater regulatory
controls to provide reasonable assurance of the device’s safety and effectiveness
- Class III (or C)
• Class III devices are generally the highest risk devices and are therefore subject to
the highest level of regulatory control. Class III devices must typically be approved by FDA
before they are marketed.

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FDA (US Food and Drug Administration),
Standards

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FDA is responsible for
• Protecting the public health by assuring that foods (except for meat from
livestock, poultry and some egg products which are regulated by the U.S.
Department of Agriculture) are safe, wholesome, sanitary and properly
labeled; ensuring that human and veterinary drugs, and vaccines and other
biological products and medical devices intended for human use are safe
and effective
• Protecting the public from electronic product radiation
• Assuring cosmetics and dietary supplements are safe and properly labeled
• Regulating tobacco products
• Advancing the public health by helping to speed product innovations

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FDA (US Food and Drug Administration)
FDA regulates a broad range of medical devices, including complicated,
high-risk medical devices, like artificial hearts, and relatively simple, low-risk
devices, like tongue depressors, as well as devices that fall somewhere in
between, like sutures. FDA has authority to regulate medical devices before
and after they reach the marketplace
*Class III devices must typically be approved by FDA before they are marketed.

10. 1010
Standarts
• ISO 13485 Medical devices -- Quality management systems
- Requirements for a comprehensive quality management system for the
design and manufacture of medical devices
• IEC 60601
- Series of technical standards for the safety and effectiveness of medical
electrical equipment
•and others...

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Let’s get started

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Feasibility studies
• Processor(s) selection
- Initial requirement, performance/cost…. (in few years they still will be on the
production line?)
• OS selection
- Based on requirements (but official support should be available during lifetime
of product!)
- Testing frameworks availability, libraries, etc
•Other components

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Device classes, does they matter?
• Documentation
• Development
• Testing

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Device decomposition
• “Module A” will have all possible formal outputs.
• “Module B” from example will require less efforts
to prepare all required (based on standards):
-Development
-UT/IT
-Test preparation
-Verification and Validation activities
• But device in general will go through “heavy”
process
To simplify and reduce some work
Content
Module A
Class III
Device Class III
Module B
Class II
Other
Modules

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SOUP (Software Of Unknown Provenance)
• You want to use some third party libraries
• The type and quality of documentation that
accompanies this software can vary
considerably.
• Software for which adequate documentation
may be difficult to obtain
• You can, but your Hazard Analysis should
encompass the risks associated with the SOUP,
regarding missing or incomplete documentation
or lack of documentation of prior testing.
• The responsibility for adequate testing remains
with you

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Side tools/application development
• Test team tools (to support testing activities)
• Initial Hardware validation
• Initial device validation in Manufacturing Line
• Translations
• Mobile application (User interaction)
• Web based solution (Data collectors, other)
• and others...
Different application can be developed to support different client’s activities and user
needs (using different programing languages):

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Few words about testing...
• That’s medical devices - we have a lot of testing with formal evidences

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Testing types and techniques
• User Acceptance Test
• Exploratory Testing
• Experienced Based Testing
• Risk-Based Testing
• Ad-hoc testing
• Black Box testing
• White Box testing
• Functional testing
• and a lot of others...
During testing of Medical devices variety
of different testing types and techniques
are used:

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Manual vs Automation
• Lifeline (long or short term project)
• Money
• Regression (next releases, fixes, new features)
• Time for full scope run

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Thank you