Clinical Evaluation Report for Medical Devices
Clinical evaluation report (CER) is a document containing information regarding clinical evaluation of a medical device. CER is intended to be reviewed by the Notified Body (NB). Clinical evaluation refers to an organized procedure (Figure 1) used to collate, compile, and analyze clinical data related to a medical device. The clinical data includes updated published information on a medical condition and the medical device which is obtained from various databases. It also includes pre-clinical and clinical data, quality control data, and risk management and post-market surveillance related inputs which are obtained from manufacturers, quality and safety scientists, respectively. The clinical information also includes the instructions to be followed while using the medical device. The CER is prepared as per the guidelines mentioned in MEDDEV 2.7/1 Rev. 4 (June 2016). It specifies the structure as well as content to be added in the CER.
Figure 1: Organized procedure followed for Clinical Evaluation of a Medical Device
(Reference: MEDDEV 2.7/1 Rev. 4, June 2016, Section 6.3)
MEDDEV 2.7/1 Rev. 4 (June 2016)
MEDDEV 2.7/1 Rev. 4 (June 2016) is the guideline followed to prepare the CER. It includes summary of CER, updated published information about medical condition for which the medical device is used, as well as complete information about device under evaluation (Figure 2).
Figure 2: Table of content for development of Clinical Evaluation Report
(Reference: MEDDEV 2.7/1 Rev. 4, June 2016, Section 6.3)
Role of Medical Writer in the Development of Clinical Evaluation Reports
Medical writer plays an essential role in development of CERs. According to the requirements of MEDDEV 2.7/1 Rev. 4 (June 2016), the medical writer performs various activities (Figure 3).
Figure 3: Role of a medical Writer in development of Clinical Evaluation Report
Turacoz Healthcare Solutions, a medical communication company, provides latest updates on medical devices. Turacoz is dedicated in providing scientific/medical writing support to the industry and academia. With expertise in several clinical trial related documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs) and Common Technical Documents (CTDs), Prescribing Information (PI), we aim to deliver the best quality and guideline compliant documents to the Pharma and different sectors of Healthcare Industry.
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This year marks the 10th World Rabies Day, which has become a global phenomenon since its beginning in the year
Turacoz is a medical communications company providing customized and cost-effective solutions to healthcare and pharma industries. The team of young,
Editing is an important task that is performed by an editor with a good scientific background and good editing skills.
Medical writing is a multidimensional profession which requires creating numerous scientific/non-scientific documents for various phases of a drug life-cycle. Different
What is Triclosan? Triclosan is commonly used as a disinfectant or an antiseptic to reduce and control the bacterial contamination.
Being a medical writer has a lot of allure, particularly if you are having a flexible work schedule, competitive salary
As the cool showers of monsoon bring relief after the torrid summers, the warm humid weather also brings numerous skin
Disturbed sleep and strained red eyes seem to take a back seat as we stand face-to-face with a much more
Viral hepatitis, an inflammatory liver disease is commonly caused by hepatitis A, B, C, D, or E virus. In 2013,
Introduction Dehydration is a condition where free water loss exceeds free water intake. Around 2/3rd of the human body is composed
Turacoz attended 6thAisa- Pacific Pharma congress organized by Omics International on 12th July,2016 at Kuala Lumpur, Malaysia.The aim of the
Humans were designed to move around and stay physically active. However, over the period of time, we evolved technologically and
Diabetes mellitus (DM) has become one of the most challenging health problems in the 21st century. It is a serious
Helen Adams Keller (June 27, 1880 – June 1, 1968) was an American author, political activist, and lecturer. She was
It’s again Ramadan time. Millions of Muslims fast during this period and abstain from eating and drinking. However, two main
Turacoz Healthcare Solutions, a medical communications company will be attending 6th Asia-Pacific Pharma Congress where, Dr. Namrata Singh, director of
Surya Namaskar or sun salutation is a way of saluting sun, the ultimate source of energy and life on earth.
Men’s Health Month is a special awareness period for men’s health observed across the globe. It was passed by Congress
Ramadan is a holy month for Muslims in which consumption of food and drinks, medications, and smoking is forbidden between
Turacoz skill development program conducted a medical writing workshop on publication at Tata memorial hospital, Mumbai on 4th June,2016. The
Turacoz skill development program conducted a seminar on 02 June, 2016 in Center for Faculty Development (Faculty of Pharmacy), Jamia
It’s not just a pain.It’s a complete physical, mental, and emotional assault on your body. -Jamie Wingo May is declared
Turacoz Skill and Development program under the umbrella of Turacoz Healthcare Solutions successfully organized its second Medical Writing workshop in
The month of May is declared as “National Asthma and Allergy Awareness Month” by Asthma and Allergy Foundation of America.
“For Hepatitis, Prevention is the Best Intervention” The month of May is titled as “Hepatitis Awareness Month”, as a proactive
Malaria is a serious life-threatening parasitic disease caused by parasites known as Plasmodium vivax (P.vivax), Plasmodium falciparum (P.falciparum), Plasmodium malariae
Turacoz Healthcare Solutions conducted a medical writing workshop on 16th April, 2016 at Country Inn and suites by Carlson, Bangalore.
Let’s Join Hands to Fight Against Hemophilia Hemophilia is one of the oldest known genetic bleeding disorder which is caused
The Department of Pharmaceuticals (DoP), Government of India, released Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) on 1st January 2015.
Autism is a serious, lifelong developmental disability characterized by considerable impairments in social interactions and communication skills, as well as
World Parkinson’s Disease Day: 11th April, 2016: World Parkinson’s disease day is celebrated every year on 11th April to commemorate
Tuberculosis (TB) is an infectious disease caused by the bacillus Mycobacterium tuberculosis. It usually affects the lungs (pulmonary TB), but
Overview : Colorectal cancer is the abnormal growth of cells in the colon or rectum (parts of the large intestine) that
World Glaucoma Week (March 6-12, 2016) : Be Informed, Be Safe Each year the World Glaucoma Association (WGA) and the
World Kidney Day (WKD) is a joint initiative of the International Society of Nephrology (ISN) and the International Federation of Kidney
Turacoz conducted a seminar on Medical writing as a career for over 125 students with Biotechnology and Life sciences background
Turacoz conducted a Medical writing workshop on February 16th, Tuesday at Radisson Blu GRT, Chennai. It is one of the
Turacoz’s Medical Director, Dr. Namrata Singh was present at the InnoHealth conference held on February 5th at PHD house, Chamber
Turacoz Healthcare Solutions conducted a Medical Writing Workshop in Dubai on 30th January 2016 at Radisson Blu Downtown. The participants
Arab Health Congress is one of the biggest, largest and most extravagant confluence for the pharmaceutical and healthcare professionals. It
February 12 is declared as Sexual and Reproductive Health Awareness Day annually. This day provides an opportunity to raise awareness
Air pollution is the introduction of chemicals, particulate matters or biological materials in air, for a sufficient time that causes
What is a Publication? Publications are a healthcare solution which bridges communication of research conducted to the researchers around the
“Anyone who stops learning is old, whether at twenty or eighty. Anyone who keeps learning stays young. The greatest thing
Practice Flawless English for Good Scientific Writing Knowledge of grammar is one of the keys to writing clearly and credibly.
It is believed that around 1920, a deadly virus crossed species from chimpanzees to humans in Kinshasa (Africa), and led
World AIDS Day, 1 Dec was first declared by the World Health Organization and the United Nations General Assembly in
‘Medical writing’ is a perfect amalgamation of science and art. As a medical writer, one has to maintain a good
As described by the WHO, immunization is the process whereby a person is made immune or resistant to an infectious
Over the years there are many technological advancements that came into light in the treatment of diabetes. These technological advancements
Clinical studies are conducted to test the drugs and medical devices in humans before their approval and availability for the
Reduce your risk today: Eat healthy, Walk more and Weigh less Lifestyle modification for prevention of diabetes mellitus Structured programs
Publishing the results of a study completes the research conducted. As mentioned by EH Miller, “If it was not published,
Knocking out Triple Negative Breast Cancer: A new paradigm in treatment Triple negative breast cancer (TNBC) are the subtypes of
Liver cancer: Treatment Liver cancer treatment is generally based on the stage of disease and the patient response to treatment.
Since 1997, October 20, is observed as the “World Osteoporosis Day” for raising global awareness on the prevention, diagnosis and
Protect yourself from Breast Cancer Over last ten years or so, breast cancer is the most common cancer in most
What is liver cancer or hepatic cancer? Liver is the largest internal organ in the body. It is essential for
“A heart for life” World Heart Day (sponsored by World Heart Federation) was founded in 2000, a biggest intervention against
September is Prostate Cancer Awareness month Globally, prostate cancer is the second most frequently diagnosed cancer in men and the
World contraception day (WCD) was first conceived in the year 2007 by 10 international family planning organizations in order to
Understanding environmental health The International Federation of Environmental Health, better known by its acronym IFEH, works to impart knowledge regarding
Newborn screening test (also known as Guthrie test) is one of the successful innovations in the modern era. It is
Fast Facts 2 A genetic disease, resulting from environmental (gluten) and genetic (HLA and non-HLA genes) factors. Estimated 1 %
Attempting Suicide and having suicidal tendency are the most extreme form of self-harming behaviour exhibited by humans. Centre for Disease
Psoriasis is not all of you, it is just a part of you like everything else Psoriasis is generally classified
Dr. Namrata’s mantra for life is “nothing is impossible”. Her experience of 10 years as a pediatrician and 9 years
Today on Organ Donation day, Turacoz team members pledge their organs for a noble cause and want to contribute to
“Once you choose hope, anything’s possible.” Christopher Reeve Sarcoma, may be defined as “a malignant tumor of connective or other
The 5 tips for desktop workers are absolutely essential to maintain and good health and have a long innings professionally.
Ramadan is a lunar based fasting month for Muslims. Muslims who fast during this time should refrain from eating, drinking,
Sarcomas are the tumors originating from mesenchyme and contribute to about 20% of all pediatric solid malignant cancers and less
Yoga has been an integral part of India since Indus Saraswati civilization for about 5000 years now. With time the
Asthma is a worldwide disease affecting an estimated 300 million individuals globally. Some authors also reported prevalence of Asthma as
“In three words I can sum up everything I’ve learned about life: it goes on.” ― Robert Frost Hemophilia- a
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