It is imperative to engage a testing company with expertise in regulatory compliance and contamination control to ensure the safety and efficacy of your devices and cleaning and disinfection processes. Our testing services help you ensure the safety of your staff and your patients. Our testing facilities are specifically tailored to both reusable and single-use medical device testing requirements.
  • FDA registered
  • ISO/IEC 17025:2017 accredited
  • GLP/cGMP compliant
Reusable Medical Device Tests

Reusable Medical Device Tests (GLP Compliant)

Every Reusable Medical Device must be reprocessed before reuse to ensure risk of contamination is minimized; this includes cleaning and either sterilization or disinfection. Before any device can be brought to market, the process for each of these must be validated to prove efficacy. Whether validating Instructions for Use (IFU) already developed or helping to create new with our guidance, we’ll develop a separate testing protocol for each processing category applicable.

In cases where reprocessing parameters are not ready for validation, we’ve got the experience and knowledge to test parameters in a non-regulatory, R&D setting and finalize reprocessing instructions ready for the validation phase.

Single Use Medical Device Tests

Single-Use Medical Device Tests (cGMP Compliant)

Ensuring patient safety is paramount, and maintaining control over your manufacturing spaces is critical in doing so. We provide cGMP product testing, disinfection qualification and environmental monitoring services to keep you in control and your customers safe.

More Solutions

Reusable Medical Device

Reusable Medical Device Validation Categories

  1. 510(k) Support
  2. Sterilization (Steam)
  3. Dry Time
  4. Disinfection (low level, intermediate level, high level)
  5. Manual and Automated Cleaning (with quantitative endpoints – protein, hemoglobin, carbohydrate)

USP <1072> Disinfection Qualification Testing

  1. Tube Dilution Method
  2. Coupon Testing Using Immersion Recovery Method
  3. Environmental Isolates and Viruses

High Level Disinfectant

  1. Simulated use testing on flexible endoscopes
  2. Bench testing, simulated use and in-use

Blood Glucose Meter / Point of Use Devices

Cytotoxicity Testing / Rinsing Studies

Single-Use Medical Device

USP <61><62> Suitability Tests

USP <61><62> Product Testing

Growth Promotion Testing of Plates USP <61><62>

Microbial Identification

Bacterial Water Analysis

USP <85> Bacterial Endotoxin

USP <161> Bacterial Endotoxin and Pyrogen Tests for Medical Devices

ANSI/AAMI/ISO 11137 Bioburden for Medical Devices

AAMI Gamma and E-Beam Irradiation Validation

AAMI Sterility

Enivronmental Monitoring

USP <71> Sterility Suitability

USP <71> Membrane Filtration Sterility

USP <71> Direct Transfer Sterility Test

Sterility Testing of Biological Indicators

USP <71> Growth Promotion

Package Integrity Testing

Water Chemical Testing

Bacterial Water Analysis

Compressed Air/Gas Testing

USP <55> Biological Indicators-Resistance Performance Tests

We’d love to talk about your project!

Resources at your fingertips

Whitepaper

Creating Adequate Reusable Medical Device Reprocessing Instructions

Whitepaper

Disinfection Qualification Testing
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