CE Marking For Software As Medical Device

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CE MARKING FOR SOFTWARE AS MEDICAL DEVICE (SAMD)
www.mavenprofserv.us
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Overview
What is Software as a Medical Device (SaMD)? Key
characteristics of Software as a Medical Device
Examples of Software as a Medical Device How
MAVEN can help with MDR Software CE Marking?
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What is Software as a Medical Device (SaMD)?
Software as a Medical Device (SaMD) refers to
software that is intended to be used for medical
purposes on its own, without being part of a
hardware medical device. In other words, SaMD is
software that functions as a medical device and
is designed to perform medical functions without
being tied to a specific piece of hardware.
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CE marking is a mandatory requirement for
Annex-XVI products sold within the European
Economic Area (EEA).It indicates that a product
has undergone the necessary conformity
assessment procedures and meets the essential
health, safety, and environmental protection
requirements set out by the European Union (EU).
CE marking provides assurance to manufacturers,
distributors, and end-users that the product is
safe and compliant with applicable regulations.
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Key characteristics of Software as a Medical
Device

1. Independent Functionality
2. Medical Purpose
3. Regulatory Oversight
4. Wide Range of Applications
5. Risk Classification
6. Conformity Assessment

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Examples of Software as a Medical Device
Diagnostic software Software used for the
interpretation of medical images or laboratory
test results. Clinical decision support systems
Software providing recommendations to healthcare
professionals based on patient data.
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Monitoring and alerting software Software used
for continuous monitoring of physiological
parameters and issuing alerts in case of
abnormalities.

• Health information systems Software managing and
  processing patient health records for healthcare
  providers.

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How MAVEN can help with MDR Software CE Marking?

• Specialized Expertise in SaMD Compliance
  Strategic Alignment with Regulations Streamlined
  Regulatory Documentation
• Proactive Approach to Regulatory Changes

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Contact Us
https//mavenprofserv.us/ce-marking-for-software-
as-medical-device-samd/
md_at_mavenprofserv.us