CE mark for medical devices

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CE Mark for Medical Device
www.mavenprofserv.com
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Technical File Clinical Evaluation

• Medical Device Testing UDI Labelling
• Medical Device Quality Management System
• Post Market Surveillance

Content
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Technical File
The technical file for medical devices refers to
all the documents that a medical device
manufacturer has to submit to NB or CA for
review approval for CE certification. The
technical file serves as a comprehensive document
that provides evidence of compliance with UK
regulatory requirements for medical devices. It
is used for the UK Conformity Assessed (UKCA)
marking process and demonstrates that the device
is safe and performs as intended.
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Clinical Evaluation
Clinical evaluation enables manufacturers to
provide sufficient clinical evidence for
demonstration of conformity of the device with
the general safety and performance requirements.
The clinical evaluation process is essential for
demonstrating that the device meets its intended
purpose and is safe for patients.
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Medical Device Testing
Medical device testing indicates that a Medical
device is certified to perform as per intended
use. The medical device
testing provides evidence of its and
compliance with standards
regulations around the globe.
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Testing medical devices in the United Kingdom
(UK) is a crucial step in ensuring that they
meet regulatory and safety standards before they
can be placed on the market. The testing process
involves various assessments and evaluations to
confirm the device's safety, performance, and
compliance with applicable regulations.
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UDI Labelling
The UDI is a series of alphanumeric characters
which is designed to provide a globally accepted,
single harmonized identification. It allows
clear and distinct identification of a medical
device. These regulations have introduced an
identification system for medical devices based
on Unique Device Identifiers UDI.
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Medical device Quality Management System
It is an organized system of processes
encompassing all critical aspects of an
organization that must be adhered to in the
quest for designing, developing, and
manufacturing medical devices. Medical Device
Quality Management System(MD QMS)
Medical Device Quality Management System (MDQMS),
is a systematic procedure and process covering
all the aspects of design, manufacture, and dist
ribution. MDQMS is required for all medical devi
ce and the complexity will vary with varying
risk class of medical device.
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Post Market Surveillance
Post-market surveillance (PMS) is a system that
provides continuous feedback about a device on
the market in order to maintain a high standard
of product quality. Post-market surveillance
(PMS) is a system that gives continuous feedback
about the performance of devices on the market
in order to maintain a high standard of product
quality.
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