If you’re thinking about adding design engineering resources for a development project, first check out this comparison of the impact of hiring an employee versus using outsourced development resources.  See our Case Study titled "Outsourced Product Development" at the following link. http://www.e-qsolutions.com/case-studies#outsourced-product

"Maximizing Margins with DFM" is an article by Orthopedic Design Technology magazine looking at the DFM trends in the medical device industry. I feel analyzing DFM & DFA is an important step in the product development process that EQS applies to almost every project, and I was so pleased to be able to provide insight for this article.  We'

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  There are draft guidance documents issued by the FDA to help companies navigate these questions, and recent updates have bee

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.  Th

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.&

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 & service