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Medical Device Biological Evaluation Report

We compile a comprehensive report that consolidates all data used to evaluate the biocompatibility of your medical device.

ISO 10993-1 - Biological evaluation of medical devices
Meets the requirements of FDA/MDR
Provides comprehensive ISO 10993 report
Completed by in-house toxicologist (competent person)

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ISO 10993-23 Test for Irritation

We offer ISO 10993-23 in vitro irritation testing to assess the irritation potential of medical devices, eliminating the need for animal testing.

Good Laboratory Practice GLP study
Biological Evaluation Plan and Report
ISO 10993-23 - test for irritation - in vitro methods

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Extractables & Leachables (E&L) Testing

We provide comprehensive Extractables & Leachables (E&L) testing to detect and measure substances released from your product, ensuring biocompatibility and meeting regulatory requirements.

ISO 10993-18
USP<1663>/<1664>,USP<665>/<1665>
Aligned with MDR and FDA guidance
Custom Extractables Stufy Design

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ISO 10993-5 Cytotoxicity testing

We offer ISO 10993-5 in vitro cytotoxicity tests under GLP conditions to assess biological risks arising from the chemical composition of medical devices.

Good Laboratory Practice GLP study
Biological Evaluation Plan
Biological Evaluation Report
ISO 10993-1 - cytotoxicity- in vitro methods

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Medical Device Biocompatibility Testing

We provide testing services that assess cytotoxicity and evaluate biological risks associated with the chemical composition of medical devices.

Biological Evaluation Plan and Report
In Vitro and InVivo methods
Extractables and Leachables (E&L) Studies
Also testing after cleaning, disinfection & Sterilization

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Medical Device Biological Evaluation Plan

We conduct Biological Safety Evaluations in accordance with ISO 10993-1 to identify and assess potential biological hazards and risks related to the clinical use of your medical device.

ISO 10993-1 - Biological evaluation of medical devices
Meets the requirements of FDA/MDR
Provides comprehensive ISO10993 testing plan
Completed by in-house toxicologist (competent person)

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IEC 60601-1 Testing and Certification

We assist you with testing and certifying your medical devices and systems in compliance with national and international standards and regulations, including the application of the IEC 60601 series.

ISO 17025 Accredited testing program
IECEE CB Scheme testing and
US-NRTL certification according to ANSI/AAMI ES60601-1 and CAN/CSA-C22.2 No.60601-1
INMETRO certification for access to the Brazalian market

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IEC 60601-1-2 EMC Testing

We provide EMC testing programs for active medical devices and systems, establishing emission and immunity criteria in accordance with IEC 60601-1-2 standards.

ISO 17025 Accredited testing program
IECEE CB Scheme testing and
IEC 60601-1-2:2020 (ed.4.1) - Medical electrical equipment
Review and verification of EMC test plans, risk analysis, and user manuals

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IEC 60601-1 Pre-Compliance Evaluation

We test your device and related documentation at any development stage, helping to reduce the cost of repeated certification and compliance testing by identifying potential non-compliance issues early.