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Edges Medicare Pvt. Ltd. has the readily available DMF that contains a list of all materials in direct or indirect contact with the patient or user for its brands. EMPL Brand’s clinicals & biocompatibility testing has been undertaken (as per prescribed standards) to characterize the physical, chemical, toxicological and biological response of a material, detailed information has been included on the analysis of data and the summary of result. BA/BE tests have been conducted on samples from the finished, sterilized device.

Depending on nature and intended use of the investigational medical device, device performance for its actions including mechanical ,electrical, thermal, radiation and any other of this type and safety have been assessed in healthy & diseased animal model as an appropriate, demonstrating reaction to active and basic parts of the device on absolute tissue, local tissue as well as whole organ , clearly recording local ,general and systemic adverse reactions ,risks or potential risks and performance of device inline with intended use.

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ISO-10993, Biological Evaluation of Medical devices, has been followed for conducting bio-compatibility study for invasive medical devices should be carried out. A report of biocompatibility study along with rationale for selecting specific tests carried out should be prepared including conclusion of the study.

EMPL Brands Biocompatibility testing, which is regulatory requirement for demonstrating the preclinical safety of medical devices has been conducted in line with the standard, ISO 10993-1:2009/Cor 1:2010 (E), Biological Evaluation of Medical Devices - Part 1, Evaluation and Testing within a Risk Management Process. This standard describes the necessary test selection to evaluate the biocompatibility of medical devices.

Standard Description
1 Biological Evaluation of Medical Devices - Part 1, Evaluation and Testing within a Risk Management Process, ISO 10993-1:2009/Cor 1:2010(E).
2 Biological Evaluation of Medical Devices - Part 2, Animal Welfare Requirements, ISO 10993-2:2006(E).
3 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity, ISO 10993-11:2006(E).
4 Biological Evaluation of Medical Devices - Part 12, Sample Preparation and Reference Materials, ISO 10993-12:2012(E).
5 CRC Handbook of Toxicology. Edited by M. J. Derelanko and M. A. Hollinger.
6 OECD Principles of Good Laboratory Practice. OECD Environmental Health and Safety Publications, Series on Principles of Good Laboratory Practice and Compliance Monitoring No. 1. ENV/MC/CHEM (98)17.
7 General Requirements for the Competence of Testing and Calibration Laboratories, ISO/IEC 17025:2005(E).
8 Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices, ISO 10993 - Part 1. Evaluation and Testing Within a Risk Management Process. Guidance for Industry and Food and Drug Administration Staff. June 16, 2016.