A european consensus approach | Writing for Medical Devices

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A EUROPEAN CONSENSUS APPROACH -----------------
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WRITING FOR MEDICAL DEVICES
2017-2018 All Rights Reserved, No part of this
document should be modified/used without prior
consent PEPGRA Healthcare Pvt Ltd INDIA
Nungambakkam, Chennai, 600 034. UK The
Portergate, Ecclesall Road, Sheffield, S11 8NX.
Emailinfo_at_pepgra.com, Webwww.Pepgra.com.
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The regulatory medical writer needs to possess
basic abilities and proper understanding of the
critical information about important regulatory
checks and must be able to develop and present
contents that conform to the regulatory
requirements relating to medical devices. The
regulatory medical writers job is not all about
producing and writing contents but also include
good project management and presentation skills.
The medical device writer must have a complete
knowledge regarding safety and efficacy of the
medical devices, precision, and validity of
measurement devices and sensitivity and
specificity aspects while writing about
diagnostic equipment. Devices undergo continuous
and rapid innovation leading to shorter
life-cycle for medical devices. Thus the medical
device writers must continually update the
subject knowledge and various regulatory
guidelines that control the usage of medical
devices.
A European Consensus Approach - Writing For
Medical Devices The requirements for medical
writing are witnessing continuous growth
influenced in good portion by the mounting
government scrutiny and regulatory controls of
companies manufacturing and marketing medical
devices.
2017-2018 All Rights Reserved, No part of this
document should be modified/used without prior
consent PEPGRA Healthcare Pvt Ltd INDIA
Nungambakkam, Chennai, 600 034. UK The
Portergate, Ecclesall Road, Sheffield, S11 8NX.
Emailinfo_at_pepgra.com, Webwww.Pepgra.com.
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European Regulatory Guidelines European
Commission for Health and Consumers has
established regulatory guidelines for medical
devices to be followed by the manufacturers of
medical devices and other associated agencies in
the marketing of such devices. European
regulatory affairs have drafted these guidelines
through an intensive consultation with able
bodies, commission services, industry agencies
and other associated bodies. The European
guidelines on medical devices provide
comprehensive information relating to the
clinical investigation, which is conducted to
evaluate the performance and safety standards of
the medical device. European medical devices
regulatory document MEDDEV 2.7.1 comprise certain
annexure that provides complete details and
description of the various regulatory aspects
involved in the manufacturing of medical devices.
Important descriptions in the European guidelines
on medical device include

• Nature and objectives of Clinical investigation
• Scope and Need assessment for clinical
  investigation
• General principles clinical investigation plan
• Ethical considerations for clinical investigation
• Clinical evidence and Clinical investigation plan
• Clinical evaluation and safety standards
• Conformity assessment
• Endpoint indicators
• Residual Risk and Risk management policies
• Relevant legal and regulatory requirements
• The European regulatory guidelines on medical
  devices provide complete explanation of clinical
  data requirements, study objectives, statistical
  considerations that can significant influence on
  the clinical performance, safety, adverse side
  effects and various risks recognized in the risk
  management process.
• Writing for medical devices should take all these
  aspects stated in the European Commission
  guidelines into consideration and ensure
  developed contents have complete confirmation of
  these guidelines. Thus, Regulatory writers need
  to hone the essential skills, gain sufficient
  regulatory knowledge and experience at every step
  from medical device prototype development and
  submission process to excel in the high
  specialized field of the medical regulatory
  writing of medical devices.
• About Author Dr.Nancy, Editor-in-chief,
• PEPGRA Healthcare Pvt Ltd.

2017-2018 All Rights Reserved, No part of this
document should be modified/used without prior
consent PEPGRA Healthcare Pvt Ltd INDIA
Nungambakkam, Chennai, 600 034. UK The
Portergate, Ecclesall Road, Sheffield, S11 8NX.
Emailinfo_at_pepgra.com, Webwww.Pepgra.com.