Developing a Spinal Plate Now or In the Near Future? If so, you may want to download the latest draft guidance from the FDA titled "Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway". See link below. They've released this as a DRAFT only at this time in order to gain industry comments. But it shows that the FDA

On Sept. 13 the FDA released FOUR new final guidance documents relating to 510(k) submissions - guidelines for traditional, abbreviated, special 510(k). They appear to be really harmonizing and solidifying the overall expectations for these submissions. As the names imply, these are not draft guidance documents, so expect that they will be enforced

Design History File (DHF) Remediation FDA inspectors, ISO auditors and internal quality and regulatory personnel are scrutinizing design history files more than ever, and the consultants at Engineering & Quality Solutions, Inc. have seen this first-hand while assisting clients with QMS audits and FDA inspections. DHF deficiencies are a major so

I really enjoyed contributing to this ODT article on the latest tends and technology in orthopedic product development.  It's great that ODT magazine researches and talks with industry professionals like myself to find out what's happening and get a preview on the orthopedic products that may be under development and launched soon.  I app

Design Controls for Medical Devices: Check out this presentation on Design Controls, published by the FDA. They've been publishing educational presentations and videos on many relevant topics for years; this can act as a primer on the subject, help resolve questions or confusion, and the best part is that it comes from the source! https://lnkd.in/e

Engineering & Quality Solutions, Inc. is the perfect resource for medical device start-ups and business ventures. Contact us today to get started. Part 4 – Transitioning to Internal Resources This is the final installment in a four-part series on how Engineering & Quality Solutions, Inc. can help business ventures and start-ups by consultin

Engineering & Quality Solutions, Inc. is the perfect resource for medical device start-ups and business ventures. Contact us today to get started. Part 3 – Manufacturing This is the third installment in a four-part series on how Engineering & Quality Solutions, Inc. can help business ventures and start-ups by consulting on product developme

Engineering & Quality Solutions, Inc. is the perfect resource for medical device start-ups and business ventures. Contact us today to get started. Part 2 – Quality System Development This is the second installment in a four-part series on how Engineering & Quality Solutions, Inc. can help business ventures and start-ups by consulting on pro

Part 1 – Product Development Engineering & Quality Solutions, Inc. is the perfect resource for medical device start-ups and business ventures. Contact us today to get started. This is the first installment in a four-part series on how Engineering & Quality Solutions, Inc. can help business ventures and start-ups by consulting on product dev

Thinking of hiring a consultant for a short or specialized project? Here are a few tips to make the relationship a success. Consultants allow clients to complete specialized tasks and gain extra capacity easily without hiring a full-time person. A good consultant is professional, reliable, honest and efficient but the client-consultant relationship