Profile Summary
I have expertise in Bioinformatics and other life sciences areas having more that 5 years of professional experience in various areas.
Ph.D. level scientist with more than 17 years of experience in both academia and industry. Experience in multinational corporations, managing d...
I did a PhD in Biochemistry and worked in biomedical research for the past 15 years. I have extensive experience in clinical research, scientif...
I am a multi-disciplinary researcher with more than 20 research publications in peer-reviewed journals and over 10 years of experience in resea...
Scientific Writer with 9+ years of experience with a demonstrated history of working in the Medical Device domain, SME in Clinical Evaluations ...
MDR/IVDR Focused on MDR/IVDR, CLINICAL RESEARCH TRIALS. CLINICAL EVALUATION and MQS IMPLEMENTATION. MDR/IVDR document preparation, including ev...
An accomplished, versatile, results-oriented clinical research professional with over 14 years of experience in the Pharmaceuticals & M...
An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR, ISO-10...
A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...
We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...
Qualifications: MBiochem Molecular and Cellular Biochemistry, Oxford University PhD Haematopoetic Stem Cell Gene Therapy, University of Manches...
I am a freelance medical, scientific, and technical writer with high-quality researches at Harvard Medical School proven by research papers pub...
A strong background in viorology, medical microbiology and public health qualifies me to work on COVID-19 projects (factsheets, COVID-19 at hom...
Medical/Scientific Affairs professional holding a Ph.D. degree in pharmacology with extensive academic and industry experience across various t...
1. Preparation of Clinical Evaluation Reports (CERs) in accordance with Medical Device Regulation (MDR) and 93/42/EEC Medical Device Directive ...
I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...
Experience in Lifesciences industry including over 18 years’ experience in QA, QMS, Regulatory, Manufacturing, Quality Unit (Commissioning, Qua...
I have more than 6 years experience (research and pharmaceutical industry) with a long track of success. My years as a researcher provided me ...
Published medical scientist: • Teaching classes on drug development and protocol writing at MCPHS (5 years) • Conducted several drug and device...
I performed inspections and premarket approvals for FDA for 7.5 years. I am now a Senior Consultant operating out of Switzerland. I operate a...
I am a research scientist with 9+ years of experience designing, conducting and communicating research in biotechnology and medicine. I work as...
Experienced Medical Doctor and Clinical Research Associate with a demonstrated history of working in the medical practice industry. Skilled in ...
Pharmacovigilance-7 years and CER/PMS writing
Professor Mark Flynn is the Executive Director of Global Impact Cluster for Better Health Healthcare and Treatment at the University of Newcast...
Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...
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CER required for pain relief patch$3000.00
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CE Mark for Class 1 medical device (MDD/MHRA) (rate per hour)$100.00
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Help with CER and EU MDR for a Class IIb/III medical device (rate per hour)$50.00
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A clinical evaluation report (CER) is a document required by all medical device companies that need to place a product in the EU market. It is submitted to a Notified Body (under the EU MDR) for CE Mark certification, which is required to sell or distribute medical devices in Europe. CERs are required for all medical device classifications in Europe and every medical device needs a dedicated CER.
A CER provides a detailed analysis of the safety and efficacy of a medical device, including data related to clinical trials, literature reviews, protocols and risk assessment. The document should contain the clinical evidence that supports proof of conformity to the Essential Requirements (ERs) in MEDDEV 2.7/1 Rev. 4 Annex 1 (Safety and Performance Requirements in the MDR). The document should also describe the physical and technical aspects of the device, the intended applications, and accurate references wherever applicable.
Preparing a CER can take several months and is a time-consuming and painstaking task. The clinical data included should be accurate and verified, and the product and its usage should be explained clearly as it affects the classification of the device. Medical device companies often require the help of a qualified freelance CER writer to help them prepare the document.
Data contained in the CER needs to be regularly updated even post-CE Marking. The details contained in the CER guides PMS (Post-Market Surveillance) and PMCF (Post-Market Clinical Followup) activities. The CER is not a static document. It is recommended that medical device manufacturers develop a robust process and strategy incorporating good practices to help them retain market market access in the EU, avoid any product recalls, and streamline their time and resources used to maintain the document.
Medical device companies are working hard to meet the guidelines laid down in the EU Medical Device Regulations (MDR). However, not all businesses can afford to have in-house staff dedicated to the upkeep of a CER. Working with an external team including CER strategy advisors and freelance medical writers can help them access the skills needed to put together the process and accelerate the regulatory approval process. CER authors are expected to have experience with regulatory affairs and medical device products, clinical data analysis, literature searches and technical writing.
Kolabtree’s global pool of experts include specialists who can help you take your medical device to market easily. It’s quick and easy to consult experts specialized in:
Clinical Evaluation Report (CER) Writing
EU Medical Device Regulations (MDR)
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