Engineering & Quality Solutions, Inc. will be attending the 2016 NASS annual meeting Oct. 27 – 28 in Boston. We’re looking forward to reconnecting with spine industry colleagues and learning about technical trends in spinal surgery and treatment. Please contact us to set up a time to meet in person and discuss how we can help you meet your development goals!
It's understandable that changes sometimes need to be made to improve devices that are already cleared and being marketed. Are you wondering if it's necessary to submit a new 510(k) for a device in this situation? There are draft guidance documents issued by the FDA to help companies navigate these questions, and recent updates have been made to the recommendations. So if you're unsure how changes affect your device status, make sure to revew the guidance documents. See the recent press release from the FDA about this topic at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm515174.htm
Is your team thinking of using additive manufacturing for a medical device? Additive manufacturing, or 3D printing, has become a reality in many industries including orthopedics. Several devices that leverage this technology are now on the market. They were the first to pave the way and navigate the FDA clearance process. The FDA has been researching and following the developments in additive manufacturing and now they’ve released draft guidance which covers many relevant topics including manufacturing and processing, cleaning and sterilization, testing, and more. This document titled “Technical Considerations for Additive Manufactured Devices - Draft Guidance for Industry and Food and Drug Administration Staff” is available to the public at the link below.
If your team needs assistance with a medical device project involving additive manufacturing, don’t hesitate to contact Engineering & Quality Solutions, Inc. We have experience with 3D printing applications for orthopedic devices and can help you understand the unique requirements of using this technology.
Engineering & Quality Solutions also does technical training. We’re happy to share our expertise and experiences with your team to help them become experts and increase productivity and efficiency. Common course requests are GD&T, Medical Device Design Verification & Validation, and Medical Device Quality System Compliance. If you have training needs like these or other similar topics, contact us to find out how we can help you.
I'm very excited to be presenting and learning from the many other presenters at the ASTM WORKSHOP ON ADDITIVE MANUFACTURING FOR MEDICAL APPLICATIONS in San Antonio, TX in May 2016. This workshop is sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices. Additive manufacturing can potentially offer the orthopedic industry advantages not previously available but there’s still a lot to be learned in this field. So, it's great to see industry experts sharing their knowledge to further the advancement of technology and innovation in orthopedic applications. Engineering & Quality Solutions, Inc. will be presenting independent research that was conducted in partnership with Empirical Testing Corp.
I really enjoyed giving my perspective on R&D in the orthopedic industry for this ODT Magazine article. The state of R&D in medical devices has changed over the past few years, but exciting things are still happening! Please find the article "R&D Outlook" at the link below.
Engineering & Quality Solutions, Inc. often gets asked about FDA registration and listing…Which companies needs to register and list devices? When should a new or start-up device company register? Should a contract manufacturer be registered? The rules have changed over the years and the answer depends on the company, its products & services, and other factors. The link below to the FDA website provides guidelines on this sometimes complex subject. If you’re wondering about FDA registration and device listing for your company, feel free to contact us and we can help you determine the best path.
Engineering & Quality Solutions will be attending the 2016 AAOS annual meeting March 1 – 5 in Orlando, FL. We have always found this meeting to be exciting and informative, giving everyone a glimpse of new products and of the overall direction of the orthopedic industry.
The meeting also provides great opportunities to meet peers, share perspectives and form successful partnerships. Please contact us to set up a time to meet in person and discuss how we can help you meet your development goals in 2016 and beyond!