The FDA announced it intended to overhaul the new medical device review process with the intent to improve device safety. See the AP article at the link below for more details. The review system, which includes the 510(k) submission and is the pathway used to clear most devices, has been in place for decades and may well need an overhaul in some ca

Market research projects a 35% increase in revenue from the use of pedicle screws for the global market over the next 5 years.  See article below from ODT magazine. The consultants at Engineering & Quality Solutions have designed pedicle screw systems that have received FDA clearance in the past year for our clients. If you need product de

All of these terms refer to the creation and use of computer models to analyze performance of a design. For orthopedic medical devices, these methods could help in predicting failure loads and locations, comparing performance of several design options, determining mechanical performance ranges within a product family, comparing performance of one d

Design verification and validation is a critical part of every medical device design project, and is required by the FDA and by ISO 13485:2016. By completing design verification, you confirm that design inputs were indeed met in the final design. And by completing design validation, you ensure that the final design meets user needs and intended use

Many small to mid-sized companies have issues completing their internal audits or getting real insight from their audits.  Since employees are responsible for many different areas, there may be few options for unbiased internal auditors.  Or employees may not be qualified to perform thorough audits to ISO 13485 and FDA 21 CFR 820 standard

Many medical device companies find themselves uncertain of how to meet FDA design control regulations, and overwhelmed with the associated DHF workload. Lean start-ups are focused on product innovation and launch, and therefore have few resources to dedicate to DHF documentation. Established companies have legacy product DHFs that were created year

Check out the recent story in ODT magazine, titled "Back to the Drawing Board: Designing Orthopedic Devices".  EQS was pleased to provide our inside perspective on orthopedic and spine design, and hear what others in the industry are experiencing.  It's a dynamic time in orthopedic R&D right now and this article sheds some light on so

It was my pleasure to contribute, along with other industry professionals, to the latest ODT article looking at the state of R&D in the orthopedic industry. Some topics discussed are: development trends, challenges and FDA regulations in orthopedic devices. See the full article here: http://www.odtmag.com/issues/2017-03-01/view_features/out-of-

Long PD Timelines Delaying Market Launch? Tips to reduce PD timelines Are your medical device PD time lines getting longer? If you have a high impact project or a critical launch window, this can seriously jeopardize revenues. Consider these top four tips to reduce PD timelines. It’s no secret that the sooner your medical device is launched, the so

PD Bottlenecks Impacting Your 2017 Launch Plans? Tips for Successful Management of Outsourced Engineering As product development ramps up in the medical device industry, many companies are considering ways to increase PD capacity in order to meet aggressive and exciting goals; utilizing outsourced product development can be a great solution, with a