Clinical Evaluation Report

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Welcome
To
Cert3Global
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Clinical Evaluation Report

• When to update medical device CER?
• The manufacturer should update their CER based on
  ongoing clinical evaluations or on post-market
  surveillance plan.
• Every year CER required updates If the medical
  device is not expected to carry significant
  risks, then it should be updated every two to
  five years.
• When the manufacturer received new information
  from post-market surveillance that can also
  change the current evaluation.
• Importance of a Clinical Evaluation Report (CER)
  for medical devices
• If you are planning to market your medical
  device in Europe, it is mandatory to have a CER
  that complies with MEDV 2.7.1 Revision 4 and the
  Medical Device Regulation (MDR)2017/745.

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Before receiving CE marking in the European
Union, medical device manufacturers must first
prove that their devices meet the regulatory
standards set out by the European Medical Device
Regulation (MDR). The aim of the regulation is to
ensure that patients are protected from unsafe
products.The aim of the Clinical Evaluation is
to provide an independent opinion on the clinical
safety and performance of the product. Clinical
Evaluation refers to the process of evaluating
the safety and effectiveness of a medical device
before it can be placed on the market. The
evaluation includes an analysis of the risks
associated with the product as well as its
benefits. This is done through a thorough review
of the available scientific literature and
clinical studies, which are then evaluated by
independent experts.
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Our team has developed an innovative
way to write Clinical Evaluations using our
proprietary technology. This technology allows us
to streamline all the components of your CERs and
Reports. With our solution, we can produce
reports for devices you intend to submit for
approval within the next few months.Cert3Global
can help with CERCert3Globals Clinical
Evaluation Reports are written by experienced
medical writers who have worked on many
successful CE Mark applications. Our team will
work closely with your company to ensure that
your product complies with all relevant EU
legislation and guidelines.Contact us for more
information!
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For More Details Visit Here-Website-
www.cert3global.com Address- Office 54,
No58, Peregrine Road, Hainault, IIford, Essex,
England. IG6 3SZ Email- enquiry_at_cert3global.com
Contact No- 44 75488 25133