WRITING FOR MEDICAL DEVICE COMPANIES: THE ROLE OF REGULATORY MEDICAL WRITERS

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WRITING FOR MEDICAL DEVICE COMPANIES THE ROLE OF
REGULATORY MEDICAL WRITERS
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The term medical devices cover a wide range of
medical equipment from common tongue depressors
to highly sophisticated surgical and advanced
diagnostic equipment that are used in various
specialized medical disciplines. These different
types of equipment are extensively used in
various sized hospitals ranging from rural health
clinics to multi-specialty hospitals providing
tertiary patient care. Similar to medicines and
medical technologies, the medical devices are
also highly essential for maintaining proper
patient care.
In this era of liberalization, medical devices
are commonly imported in developing countries,
which potentially increase the chances of
unscrupulous commercial elements causing
significant concerns for the safety of patients
on whom the inferior quality devices are used. To
avoid this, all the main countries have
established or follow global standard regulatory
control
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Knowledge of Regulatory writing Guidelines
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The regulatory medical writers must possess
sufficient knowledge of the regulatory guidelines
to be followed for medical devices while
developing regulatory contents for such devices.
No single guideline will satisfy the requirements
of every country, and many major economies follow
country or region-specific regulatory policies
for the medical devices. For instance, some
countries have established regulations and
restrictions on the production facilities of the
devices and require Good Manufacturing Practice
(GMP) certification for its usage on the
patients. Some countries would have complex
quality controls and the respective regulatory
authorities have put in place different policies
and guidelines for the deployment of medical
device principally to safeguard their patients
from hazardous, unsafe and inferior
technologies.Thus, the regulatory medical
writer for medical devices must have a good
understanding of the standardized regulatory
guidelines commonly used by major economically
developed countries. Major global healthcare
agencies like WHO and European commission have
established regulatory guidelines for medical
devices that are considered to be good standards
and followed in many countries
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Important challenges of regulator writers of
Medical Devices
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1. Limited publications are available for medical
device writing as compared to writing in
pharmaceutical activities and fewer patients
per 2. Medical device writing necessitates
writers to undergo frequent product updates
particularly laboratory software and diagnostic
devices 3. Regulatory requirements vary
significantly depending on the class of device
and hence device writers should have sufficient
understanding of regulatory requirements of
different devices 4. Medical equipment
manufacturing companies give more emphasis for
commercial activities and relatively less
emphasis on publishing particularly diagnostic
equip-cal devices. Thus, a good knowledge of
various challenges faced by the sector will
enable the regulatory medical writers to develop
competence and become an expert writer in the
field of regulatory medical writing relating to
medical devices.











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