Posted February 21st, 2012 by ETC
A huge thank you to all who were able to attend our most recent ETC Satellite Event, “Maximizing Efficiency in Orthopaedic Product Validation Testing: The Latest Guidance” . If you were unable to join us at the InterContinental Hotel in San Francisco on February 9, 2012 and are interested in learning more about the four presentations that were given, please click the appropriate link below:
To receive updates on upcoming events and to keep up to date on the latest happenings with ETC be sure to join our mailing list and as always feel free to contact us with suggestions on what topics you’d like to see discussed at future events!
Posted January 6th, 2012 by ETC
SAVE THE DATE for Empirical Testing Corp.'s second ever Satellite Event! Whether you were able to join us in Chicago this past November or not, be sure to mark your calendar for this event and pass the word along to any colleagues who may be interested in joining you. The program will feature leading experts presenting the latest guidance for spine and orthopaedic product testing, a lightning round panel discussion and a complimentary lunch. If you would like to receive updates as we get closer to the event, or to receive information on future events, please email our Customer Focus Specialist, Kimberly Rokicki, at krokicki@empiricaltesting.com. We look forward to seeing you there!
Posted December 19th, 2011 by ETC
Empirical Testing Corp. participated at the ASTM Symposium on Static and Dynamic Spinal Implants: Are We Evaluating Them Appropriately? held November 16, 2010 in San Antonio, TX. Our President and CEO, Dawn Lissy, along with our Technical Manager, Mike Anderson, gave an oral presentation on the topic of ASTM F2624 – Evaluating Alternate Fixtures for Flexion/Extension, Lateral Bending and Axial Rotation Testing of Extra Discal Motion Preserving Implants. A print version of the manuscript for this study will be published in February 2012; however, as of December 12, 2011 a copy was made available online. Feel free to download a PDF version of this paper by clicking here.
Posted December 14th, 2011 by ETC
Megan Peters began working for Empirical Testing Corp. in September 2007 as the Director of Operations. With a B.S. in Chemical Engineering, she spent the first fifteen years of her career with two large semiconductor companies, first as a process engineer and later as an engineering manager. "Working for ETC was an adjustment, as there were very few of the systems in place that I was accustomed to for managing people and running the lab. That ended up being a big plus, as I have been able to develop a great staff, create systems that work for us as a small company, and help to support ETC's continued growth", explains Peters.
When a company is already built on a solid foundation it becomes easy to promote future growth from within. At Empirical Testing Corp., we pride ourselves on tapping into the wealth of experience and creativity that already makes up our team, helping fan the flames of progress and innovation. The culture in which ETC operates is one of continued improvement, and Ms. Peters' recent promotion to Vice President of Operations will grant ETC a competitive advantage. Operational excellence stems from teamwork and maximizing the flow of value to the customer. With strong leadership in place and a commitment to the success of the partnerships Empirical Testing Corp. cultivates with their customers, the sky is truly the limit!
Read the interview below to learn more about Megan Peters - our key to operational excellence.
Describe your current role at ETC.
MP: "I am responsible for all aspects of testing, quality, facilities, maintenance and finance for ETC."
How does what you do as the VP of Operations affect our Customers?
MP: "I help ensure that testing is scheduled and completed in a timely manner with high quality."
How has ETC changed since you became part of the team and began working here?
MP: "We have added equipment, people and services over the past 4 years that have enabled us to better serve our customers' needs."
Tell us something abour your life outside of ETC.
MP: "I have been married for almost 20 years and have 3 amazing kids. We enjoy hiking, skiing and biking."
What is your favorite part of working at ETC?
MP: "The ability to do the right things for our employees and our customers without the bureaucracy."
Posted December 12th, 2011 by ETC
On December 10, 2011, your team at ETC hosted a holiday open house for family and friends. Guests were invited to enjoy lunch and tour the new office space while learning what their family members do at work each day. Activity stations were set up for the children to learn about milling test blocks, axial compression testing, screw pullout and how to assemble specimens for testing. Check out our Facebook page to view pictures of the event. Everyone here at ETC would like to wish you and your family a very happy and healthy holiday season!
Posted November 23rd, 2011 by ETC
Some changes, such as the summer leaves turning to the brilliant colors of fall (one of the things I miss from Ohio) and the start of football season, are most welcome. Others, including the start of another school year and trying on last years's winter coat that miraculously "shrunk" two sizes over the summer, less so. Omnipresent in nature, change constantly influences our lives, and while more often than not, we cannot control the actual act of change, we can do our best to understand why it is happening and what we can do to deal with the effects.
One area of all of our professional lives that seems to be constantly changing these days is the regulatory controls set forth by FDA and other regulatory agencies. Last year, CDRH set out to revamp the 510(k) process, and some of the new controls are just starting to be rolled out. While we can do our best to influence the change through forums and town hall style meetings, the most proactive approach is to quickly deal with the effects as they come. Working with qualified vendors and suppliers is an effective way to arm yourself with the experience you'll need to weather the storm and adapt to changes surrounding regulatory approval in the U.S. With more OUS regulatory authorities requiring additional mechanical testing and requirements more stringent than ever before, ensuring that your partners have internationally recongnized accreditation and are maintaining current knowledge about international markets is more critical now than ever before.
Some changes come at opportune times, though, and are greatly welcomed. I'm proud to announce that Empirical Testing Corp. is changing locations! Don't worry - we're still in Colorado Springs, but we have annexed the office space next door and are expanding into an additional 10,000 sq. ft. of space for more staff and more equipment. This expansion will allow us to continue to add to our selection of services while still keeping the same level of quality you have come to expect from ETC. Our ability to partner with you from design freeze to commercialization of your device is stronger than ever, and we're extremely excited about the changes happening all around us here.
I've found that to successfully combat the effects of adverse change, we must adapt to them and grow in spite of them. Adaptation is a key strategy to staying relevant in an industry that is constantly evolving, and one way that we hoped to help you adopt a proper strategy was to share our experience at this year's annual NASS conference. Empirical Testing Corp. hosted a satellite event during the conference. (Did I mention the event was FREE and lunch was PROVIDED!). Four top industry experts in assessment, testing and validation presented and discussed with you how to optimize use of their respective fields in the constantly changing regulatory environment.
Posted November 17th, 2011 by ETC
Thank you to everyone who helped make the recent ETC Satellite Event, “Avoiding Pitfalls in Product Development: Advice from the Testing and Validation Experts” a huge success! If you were unable to join us in Chicago on November 3, 2011 and are interested in learning more about the four presentations that were given, please click the appropriate link below:
With the accomplishment of our first experience of this kind behind us, you can be sure that we will be hosting similar occasions in the future. Don’t forget to join our mailing list to be notified of all the happenings at ETC and as always feel free to contact us with suggestions on what topics you’d like to see discussed at future events!
Posted November 2nd, 2011 by ETC
Quality Assurance has always been second to none at Empirical Testing Corp. ISO/IEC 17025:2005 accredited by The American Association for Laboratory Accreditation (A2LA) since 2002, ETC has been continually developing our scope of accreditation while instituting lean practices. Now Empirical Testing Corp. is furthering our commitment to our customer's success by creating a department whose sole focus will be quality assurance.
Catherine Lehman has been a test engineer with Empirical Testing Corp. for more than seven years. While also acting as the Deputy Quality Manager, since 2008, she has played an integral party in the creation and maintenance of various quality control systems. "Quality has always been at the top of ETC's priority list. Our quality system is forever evolving and it was concluded that the next logical step was to create a separate department whose entire focus would be on quality." states Ms. Lehman. Her new position as Quality Manager will shift Ms. Lehman's concentration from job ownership on the lab floor to an exclusive responsibility toward quality. The addition of this new position will ultimately allow for greater efficiency throughout a job's life cycle. "ETC understands the link between quality and efficiency as well as the strict deadlines our customers are up against." notes Lehman, "For our customers, this change will mean faster turnaround while eliminating possible opportunities for errors."
Ms. Lehman's new duties will encompass all aspects of a successful quality assurance system including the performance of laboratory observations in order to proactively uncover ways to improve overall quality and efficiency, weekly 5S audits for lean systems maintenance and quality audits several times a month. "The ultimate goal of these tasks is to focus on preventative actions; however, if an opportunity is identified, we direct our attention to solving the ultimate root cause and determining sustainable corrective actions." explains Lehman. "For this reason ETC goes an additional step by further evaluating all corrective and preventative actions put into place in order to establish their effectiveness. We feel it is important to work toward a solution that makes sense and has purpose rather than just finding a quick fix."
ETC recognizes that the long term solution to improving quality is the sustainability of the processes we put into place; because of this, management has proactively adopted a stance toward open communication between team members. Daily "stand-up" meetings to review the day's activities have proven beneficial in promoting an open dialogue while ensuring all employees feel comfortable voicing their ideas and suggestions for ways to improve upon processes and procedures. Aristotle quoted, "Quality is not an act, it is a habit"; at Empirical Testing Corp. quality is a habit that we cultivate.
Visit our website at www.empiricaltesting.com/quality to view our A2LA ISO/IEC 17025:2005 Scope of Accreditation and experience our commitment to quality or feel free to contact us directly at (719) 264-9937.
Posted October 18th, 2011 by ETC
Share your thoughts and ideas on testing projects, while enhancing your medical device experience by participating in our Post Job Satisfaction Surveys. Now you don't have to wait for your email invitation to get in on the action, feel free to fill out our survey by clicking here. We take your input seriously and implement new programs and support like our "next day" services and sterilization validation, based on your needs.
Beginning October 1, 2011, to show our appreciation for participating in our survey, you will be entered into a quarterly raffle to WIN $100 in your choice of an Amazon.com gift card or a donation made in your name to a charity of your choice!
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.
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