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What medical products need regulatory testing? How do contract testing companies work? Medical devices guidelines and regulations for FDA and ISO approved test results. We are a contract testing organization based in Rhode Island. If you have questions, we have some answers here.
Frequently Asked Questions
Ethide Laboratories is an ISO 13485 certified facility. ISO 13485 is a stand-alone quality management system standard that adapts the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 certified facilities (as Ethide Labs) ensure the consistent design, development, production, installation, and delivery of medical devices and products that are safe for their intended purpose. As an ISO 13485 certified facility, Ethide provides testing services that meet industry standards.
Ethide Laboratories testing follows procedures for American Society for Testing and Materials (ASTM), American National Standard (ANSI), International Organization for Standardization (ISO), United States Pharmacopeia (USP), and Associate for the Advancement of Medical Instrumentation (AAMI) guidelines. AAMI puts out technical information reports (TIR) guidelines and other documents that provide testing standards. Ethide Laboratories also incorporates the latest FDA guidelines in their testing methods.
The medical device testing methods for your product or device will depend upon the device’s intended use, medical device packaging selection, the materials used to create the medical device, and terminal sterilization methods. Please get in touch with us for specific questions related to the tests required to get your medical device FDA approved. See our section above, “What regulations does Ethide Laboratories testing follow,” for a list of the primary standards that must be followed for FDA and ISO approved test results.
Medical products and devices must prove that they are safe for human use and stable until their expiry before they can be sold in the United States or other countries. Regulatory testing is needed to confirm that new or modified medical products and devices meet the required FDA standards for human use.
Ethide Labs has over 50 years of experience serving companies and supporting them with getting new products and devices to market.
Ethide Labs has a rigorous Quality Management System in place to ensure accurate results for all testing services. Ethide Labs stays on top of all testing standards revisions and performs comprehensive gap analysis on any new versions of guidance or standards before undertaking product testing. Also, our quality department reviews all test reports before delivery to ensure excellence.
Each type of test (bacterial endotoxin testing, cytotoxicity testing, etc.) is governed by different regulatory guidelines based on the intended use of the device and the patient contact method. Please see our section above on “What regulations does Ethide Laboratories follow?” for more information on the regulations that may pertain to your testing needs.
Test samples can be shipped directly to our main address below along with a filled Test Request Form using any major shipping carrier. A completed TRF can be emailed to [email protected] for a prompt response.
Ethide Laboratories operates from our company headquarters in Warwick. We are a contract testing organization for medical devices and products in Rhode Island. Our Address: 1300 Main Street, West Warwick, RI 02893, USA.
After filling out our Contact Form, you can expect a response from one of our staff members within 1 business day. Once appropriate test methods have been selected, the payment method is confirmed, and product samples have arrived, testing can commence.
Each medical device is unique. Our regular turnaround times vary by the types of testing requested and testing outcomes. In rare cases, test results are inconclusive. In this case, additional testing will need to be performed to confirm a pass/fail result. Please get in touch with us for an accurate timeline for testing your products.
Test results and reports will be emailed to a client-designated point of contact.
Ethide Laboratories adheres strictly to the terms of nondisclosure and confidentiality agreements. Client anonymity and product information safety are guaranteed unless explicitly stated otherwise.
Why Should You Choose Ethide Laboratories over other contract testing companies?
Ethide Labs provides testing services that offer great value for your money. We understand that time is of the essence in getting your medical device to market, and we have assisted over 500 companies successfully over the years. Many of our new clients approached us because they were not offered personalized guidance, timely testing, or reasonable pricing from large labs. We take care of our customers, and no project is too small for us. We specialize in assisting small to medium companies in getting their products to market. More importantly, we don’t charge consulting fees to provide insights into testing requirements for your products. We are always available for all our customers if they have questions about past, current, or future testing. You’ll find we emphasize greatly on timely customer service, which is our key differentiating factor.
Additionally, our approach to communication, speed, and standards for excellence differentiates us from other contract testing companies. We provide communication with our clients every step of the way, such that our clients receive near-immediate responses to their requests. Further, we communicate with our clients regularly during the laboratory testing process, providing consistent progress updates and access to reports as soon as they are available. Additionally, Ethide provides seamless internal communication amongst our staff and various departments. At Ethide, intradepartmental communication is fluid instead of modular. Since our departments are in constant communication and coordination with one another, we are able to provide cost-effective solutions and regulatory testing speed with excellence. In larger corporations with multiple locations, departmental communication is often delayed and inefficient due to the volume of personnel being managed and strict organization-wide protocols. While Ethide has only a single base of operation, we shine in our capacity to bring efficient intradepartmental communication, quick client response time, testing excellence, and speed.
