Showing posts tagged with industry.
Posted April 8th, 2011 by ETC
Empirical Testing Corp.'s Non-Testing services, such as our educational courses geared toward product development and test engineers, have been a success! Now ETC is thrilled to announce that we are growing those services to include the following areas of research support:
- Device and Package Evaluation
- Sterilization Validation
- Packaging Validation and Testing
- Testing Methodology and Protocol Generation
- Literature Research
- White Paper Drafting
- Preliminary Patent Searches
- Report Generation
- Quality Systems and Documentation Development
At ETC, we understand today's highly competitive field of medical devices. Companies will often face numerous time consuming obstacles while developing a product development timeline, and in a world of stiff financial resources, accelerating that timeline while preserving the efficacy of your device is essential.
Meredith May is the new Validation, Certification and Technical Specialist who has been brought aboard to oversee these newest additions to ETC's services. "The FDA is pushing for cooperation between academia and industry, which means that there is a greater need for clinical and biomechanical research for regulatory submissions," explains Ms. May. "Additionally, Empirical Testing Corp. is also expanding to include sterilization validation testing in order to come closer to providing customers with the "one stop shop" for medical device testing. The sterilization validation testing package includes protocol generation, sterilization parameter identification, validation and report generation." continues May. Having the ability to save time and valuable momentum by partnering with a company that can offer support and expertise beyond testing puts ETC's customers at a definite advantage. May says, "Empirical Testing Corp. is positioning itself to be an industry leader by providing customer specific research and protocol generation for its customers."
As regulations continue to evolve, many companies find themselves needing an expert who can navigate the system and provide the knowledge needed to facilitate moving their ideas to market as quickly and efficiently as possible. "A critical aspect of being a medical device manufacturer is having appropriate quality systems in place, including procedures and policies that will comply with industry regulations." May notes. "Empirical Testing Corp. is now also in a position to assist with development of those procedures, giving customers a better chance of success in this ever-changing and evolving regulatory environment."
Visit our website at www.empiricaltesting.com/services to view our complete list of services, including our A2LA ISO/IEC 17025:2005 Scope of Accreditation, or feel free to contact us at (719) 264-9937 to discuss how our services can give you the advantage needed while bringing your device to market.
Posted September 24th, 2010 by ETC
We are thrilled to announce the release and launch of our brand-new website! Empirical Testing Corp.’s space on the web has been overhauled top to bottom and is now more informative and user-friendly than ever before. From insider knowledge about mechanical testing, to info about our staff and facilities, as well as links from orthopaedic industry leaders, the new empiricaltesting.com is your portal for information on medical devices and your personal link to your very own mechanical testing team. Connect with ETC by browsing our all new Photo Gallery; schedule a visit to our lab; request an estimate online; subscribe to our RSS, Facebook, and Twitter feeds – there is so much to explore! Cutting-edge design and straightforward user interface allow for streamlined access to our new features, and with new content being added regularly, you will find yourself coming back again and again to see what’s new with ETC. Visit and bookmark www.empiricaltesting.com today to experience the new gold standard for yourself!
Posted April 1st, 2010 by ETC
p>ETC is taking our show on the road and looks forward to seeing you at the following conferences and meetings. Please contact Kim Rokicki at KRokicki@empiricaltesting.com or 719.264.9937 to discuss our participation and booth locations at each of the following 2010 events.
- AAOS, New Orleans, LA USA: Booth 6322 — March 10 to 12
- STS, New Orleans, LA USA: April 26
- SAS, New Orleans, LA USA: April 27 to 30
- OrthoTec, Warsaw, IN USA: Booth 408 — May 12 to 13
- OrthoTec Europe, Zurich, Switzerland: Booth 310 — September 29 to 30
- NASS, Orlando, FL USA: Booth 1354 — October 6 to 8
Posted November 23rd, 2009 by ETC
Empirical Testing Corp. is proud to have participated as a finalist for the 2009 Celebrate Technology Awards. Celebrate Technology, started in the 1990s to showcase the vibrant technological industry of Colorado Springs region, recognizes the achievements of companies and individuals that have contributed in a significant way to the technological business landscape of the Pikes Peak region. Contributors are from the following disciplines: Internet and software, bio–medical and bio-technology, space–related and homeland defense technologies, plus emerging technologies.
On November 5, 2009, ETC and other Colorado technology professionals gathered in Colorado Springs for the Celebrate Technology Awards ceremony. Proceeds from the event will be used to fund scholarships for engineering and technology students in the region. ETC looks forward to participating in the event next year.
For more information about ETC and upcoming scheduled events or conferences, please contact Kim Rokicki at 719-264-9937 or krokicki@empiricaltesting.com, or visit our website.
Posted February 17th, 2009 by ETC
Visit Empirical Testing Corp., in Colorado Springs, Colorado, and learn first-hand why we consistently exceed medical device testing needs. Here, you will observe a knowledgeable team of bio-medical engineers, a state–of–the–art mechanical testing facility, and an enthusiasm to ensure your medical device is efficiently tested and has every opportunity to swiftly get to market. You will also witness how pride for working in the medical device industry and experience informs an outstanding product: a test report that has been recognized throughout the industry for 10 years running.
The passion that drives ETC started well over 10 years ago with our president, Dawn Lissy. As an Acromed Corp. product development engineer, Ms. Lissy was responsible for new product design and development. She was partner of the Trauma-Tumor Team and managed the maintenance, manufacturing, testing, quality, marketing, and regulatory standards of a variety of product lines. She also faced the trials and tribulations of working with testing houses that demonstrated limited knowledge of the medical device industry, developed inadequate test blocks and methods for her products, and delivered unreliable test results. Those testing houses rarely communicated with her other than at the beginning of the project and when it was time to deliver their results at the end of testing. Additionally, she had to reverse engineer those test results to ensure that their reports were submittable for regulatory approval.
“That is how I grew to understand our clients’ challenges,” says Ms. Lissy. “As an engineer developing spinal implants, I had to tell test engineers what fixtures to develop and what the test blocks should look like. I only learned of product or testing issues after I received my results, so wasn’t given the opportunity to maximize my resources during the test phase. Some of the issues could have been easily resolved had I received information in a timely manner. But to understand these test reports and my products’ performance, I had to reverse engineer every report.”
Further fine tuning her grasp of test reports and their role in achieving regulatory approval, Ms. Lissy, a member of the team responsible for the development of the Stackable Cage, participated in the initiation of a ground breaking submission pathway to FDA approval.
All of this insight converged when husband, and now-ETC Vice President, Chris Lissy, suggested that Ms. Lissy turn her frustration into the opportunity of a lifetime and a product that is known world–wide for making a difference when seeking regulatory approval. On December 22, 1998, ETC was founded as a corporation in Ohio. Within their first 5 years, ETC’s facilities grew to 5,000 square feet housing 7 test frames. In 2004, the Lissy’s moved ETC to Colorado and into their current 10,000 square–foot facility. In just 2 years, the number of test frames grew from 13 to 26, with 8 more added last year. The facility also is home to 2 wear simulators.
Building a burgeoning business has been gratifying, says Ms. Lissy. “But, I was especially proud to achieve A2LA accreditation,” she adds. “With A2LA's ISO/IEC 17025:2005 certification (Certificate Number 2142.01), we are recognized as a mechanical test lab committed to operating in an environment that places quality first. It also says that we stand behind what we do.” ETC continually expands our scope of accreditation. For a complete list of ETC A2LA certifications, visit ???.
With increased business comes a larger staff. ETC started in Colorado with 4 employees and now employs a staff of 19. The Lissys went from being accountable for everything to cultivating an ability to quickly react to customers requirements. Along with the increase in square footage, test frames, wear simulators, and staff, ETC remains focused on delivering outstanding mechanical testing reports and services, including (a minimum of) weekly customer communications, “Next Day” services which allow clients to “jump the queue” when immediate testing is necessary, plus more customer site visits to keep in touch with clients and initiate enhancements to meet customer needs.
After 10 years of service to the medical device industry, there remains ground to break. With a devotion to exceed customer needs and to help drive medical devices to market, ETC is now originating and participating in research projects. “Whether we're making our own specimens and running tests,” says Lissy, “or partnering with a research institution, we are pleased to answer questions about how parameters around a device affect the performance of the device. These are questions everyone in the medical device industry asks, but does not have the time or resources to answer.”
To learn how you can benefit from working with ETC, or to schedule an onsite visit, please call 719-264-9937 or email dlissy@empiricaltesting.com.
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