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IVDR & MDR consultant - PER CER Systematic literature review Technology assessment
Alexander Langford-Smith
,
Middlewich, United Kingdom
Experience
Skills
I'm offering
Systematic Evaluations Limited specialise in producing high quality systematic literature reviews and regulatory documentation.
For the medical device regulation (MDR) and in vitro diagnostic regulation (IVDR), we specialise in performing systematic and reproducible literature reviews for: state-of-the-art, product design, clinical evaluations (CER), performance evaluations (PER), post market surveillance (PMS), post market follow up, risk management and publication. Our data services assess the quality of data, statistically analyse the data and present your data for internal reports, regulatory documents or publication.
For the pharmaceutical sector we provide medical writing, systematic and reproducible literature reviews and data analysis services, for internal reports, regulatory documents or publication.
For the financial services sector we perform independent systematic technology assessments and literature reviews to support the assessment of biotechnology investments.
For the legal profession we offer independent systematic and reproducible literature reviews to assess the scientific evidence pertinent to your case.
For the medical device regulation (MDR) and in vitro diagnostic regulation (IVDR), we specialise in performing systematic and reproducible literature reviews for: state-of-the-art, product design, clinical evaluations (CER), performance evaluations (PER), post market surveillance (PMS), post market follow up, risk management and publication. Our data services assess the quality of data, statistically analyse the data and present your data for internal reports, regulatory documents or publication.
For the pharmaceutical sector we provide medical writing, systematic and reproducible literature reviews and data analysis services, for internal reports, regulatory documents or publication.
For the financial services sector we perform independent systematic technology assessments and literature reviews to support the assessment of biotechnology investments.
For the legal profession we offer independent systematic and reproducible literature reviews to assess the scientific evidence pertinent to your case.
Markets
United Kingdom
Links for more
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Language
English
Fluently
Available
My experience
2021 - ?
freelance
Managing Director and principal medical device and in vitro diagnostic device consultant
Systematic Evaluations Limited.
We offer regulatory support to the medical devices and in vitro diagnostic devices industries and specialise in clinical and performance evaluations and the continuous update of them in post-market surveillance. We also offer systematic literature
review services to medical device, in vitro diagnostic devices, pharmaceutical and financial services industries to systematically
evaluate the evidence for the technology, design, risks or market potential of devices or therapeutics.
review services to medical device, in vitro diagnostic devices, pharmaceutical and financial services industries to systematically
evaluate the evidence for the technology, design, risks or market potential of devices or therapeutics.
Design, Pharmaceutical, Technology, Medical Devices, Support, Regulatory, Medical device
2020 - 2021
job
Senior Clinical Affairs Associate, Primary IVD Consultant
SciMed Consultancy.
I led the transition of the templates and process to the exacting standards of the MDR and IVDR regulations and the guidance of the MDCG:2020-13. I have then produced CEPs, CERs, PEPs, PERs, PMCF, PMPF documents that have successfully passed audit. I manage additional resources to maximise the rate whilst maintaining the quality of the documents produced.
2018 - 2019
job
Senior Postdoctoral Research Associate
Manchester Metropolitan University.
Evaluating the changes in endothelial cell adhesion in different physiological flow conditions using adhesome proteomics to understand the cause of a third of heart attacks.
Research
2013 - 2015
job
Postdoctoral Research Associate
University of Manchester.
Determining the effect of age, environment and genetics in the Bruch's membrane and identifying pathways involved in age-
related macular degeneration (AMD) pathogenesis, utilising transcriptomics and cell models.
related macular degeneration (AMD) pathogenesis, utilising transcriptomics and cell models.
Research, Genetics
2004 - 2004
internship
Internship
ProXara Biotechnology Limited.
Cell based drug screen of inhibitors of PKB
Internship
My education
2008
-
2012
Doctorate, Medical and Human Sciences
2002
-
2006
Trinity College University of Oxford
MBiochem, Molecular and Cellular Biochemistry
MBiochem, Molecular and Cellular Biochemistry
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