BIOMEDRIC

slider-3-1 BIOMEDRIC-The Metrics of Medical Devices and In-Vitro Diagnostic Medical Devices Specialized Areas slider-6-1 Medical Devices-Preclinical Performance Tests Medical Devices-Preclinical Safety Tests Medical Devices-Clinical Trials IVD Medical Devices-Preclinical Scientific Validity IVD Medical Devices-Preclinical Analytical Validity IVD Medical Devices-Clinical Performance and Utility IVD Medical Devices-Post-market Surveillance slider-1-1 BIOMEDRIC-The Metrics of Medical Devices and In-Vitro Diagnostic Medical Devices Consultancy Services
About Us

BIOMEDRIC, which started its activities in 2020, is dedicated to the metrics of biomedicine on medical devices (MD) and in vitro diagnostic medical devices (IVDMD). In this context, specifically, we aim to meet the scientific/technical/regulatory consultancy, reporting, and filing requirements of MD and IVDMD manufacturers, which has become a major need, especially with the new European Union Regulations on MD (Regulation (EU) 2017/745)) and IVDMD (Regulation (EU) 2017/746), as well as with the tendency of the FDA regulations. For this purpose, by eliminating the waste of time and money with accurate and fast solutions thanks to our strong scientific and technical expertise, we are providing high-quality scientific/technical/regulatory support from preclinical to post-clinical stages for MD and IVDMD manufacturers to translate their products into the clinic.

Please contact us for the high-quality scientific/technical/regulatory consultancy, reporting, and filing services you may need.

PRECLINICAL STAGE
The preclinical stage before the clinical stage (tests humans take part) provides preliminary data regarding a medical device’s safety and efficacy, and an in vitro medical device's scientific and analytical validity.
CLINICAL STAGE
The clinical stage containing tests humans take part in provides data regarding the safety and effectiveness of a medical device and the clinical performance and utility of an in vitro medical device.
POST-CLINICAL STAGE
The post-clinical stage (post-market surveillance) provides long-term data in the general population regarding whether a medical device or an in vitro medical device continues to meet the same quality, safety, and performance requirements as to when it was first released to the market.
Specialized Areas
Biological Evaluation Plan for Medical Devices
MD Preclinical Tests
2 Subcategory
REVIEW
Biological Evaluation Plan for Medical Devices
MD Clinical Trials
1 Subcategory
REVIEW
Biological Evaluation Plan for Medical Devices
IVDMD Preclinical Evidence
1 Subcategory
REVIEW
Biological Evaluation Plan for Medical Devices
IVDMD Clinical Evidence
1 Subcategory
REVIEW
Biological Evaluation Plan for Medical Devices
IVDMD Postmarket Surveillance
1 Subcategory
REVIEW
What Have We Done Until Today?
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CONSULTANCY REQUEST
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ONGOING PROJECT
Library
Biological Evaluation Plan for Medical Devices
Biological Evaluation Plan for Medical Devices
According to ISO 10993-1 (2018): “The biological evaluation of any material or medical device intended for use in humans shall form part of a structured biological evaluation plan within a risk management process in accordance...
Chemical Characterization and Toxicological Risk Assessment of Medical Devices
Chemical Characterization and Toxicological Risk Assessment of Medical Devices
The article has been adapted from the article entitled “Chemical Characterization and Toxicological Risk Assessment of Medical Devices” in the Journal of IKMIB Chemist (IKMIB Chemist, August 2021, 65, 88-91), written as an expert opinion...
FDA Regulations for In-Vitro Diagnostic Medical Devices
FDA Regulations for In-Vitro Diagnostic Medical Devices
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services, which is responsible for regulating food and medical products that are manufactured, imported, or marketed in the...
FDA Regulations for Medical Devices
FDA Regulations for Medical Devices
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services, which is responsible for regulating food and medical products that are manufactured, imported, or marketed in the...
EU IVDR 2017/746
EU IVDR 2017/746
Directive 97/79/EC of the European Parliament, which is the current regulation before EU IVDR 2017/746, includes the Union regulatory framework regarding in-vitro diagnostic medical devices. In-Vitro Diagnostic Directive particularly directs the safety, superiority, performance, and...
EU MDR 2017/745
EU MDR 2017/745
Rules and laws are today an integrated part of society. They are necessary for the safety and precautions of all that abound within a person’s daily trading and usage. The protection assumes mounting importance regarding...
Popular Topics
Biological Evaluation Plan for Medical Devices
Biological Evaluation Plan for Medical Devices
EU IVDR 2017/746
EU IVDR 2017/746
EU MDR 2017/745
EU MDR 2017/745
FDA Regulations for Medical Devices
FDA Regulations for Medical Devices
Chemical Characterization and Toxicological Risk Assessment of Medical Devices
Chemical Characterization and Toxicological Risk Assessment of Medical Devices
FDA Regulations for In-Vitro Diagnostic Medical Devices
FDA Regulations for In-Vitro Diagnostic Medical Devices
MD-Preclinical Safety Tests
MD-Preclinical Safety Tests
MD-Clinical Trials
MD-Clinical Trials
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BIOMEDRIC Staff is working remotely at this time. We can be reached by email (preferred) or by phone.
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