Engineering & Quality Solutions, Inc will be attending the 2023 NASS annual meeting in Los Angeles, California. 

www.spine.org/AM

The NASS annual meeting provides great opportunities to meet with peers, share perspectives, keep track of industry trends and form successful partnerships. 

We still have meeting slots open for Thursday, October 19. Please contact us to set up a time to meet in person and discuss how we can help you meet your medical device product development, quality system and training goals. 

Members of the Engineering & Quality Solutions, Inc. team, Victoria Trafka & Richard Brown were honored to have provided perspective for an article on orthopedic device testing and analysis in the current issue of the Orthopedic Design & Technology, ODT, magazine. See link below for full Article:

https://www.odtmag.com/issues/2023-09-02/view_features/lab-tested-industry-approved-a-discussion-of-ortho-device-testing-analysis/?widget=listSection

Engineering & Quality Solutions, Inc will have representatives attending the 2022 NASS annual meeting in Chicago, Illinois. www.spine.org/AMThe NASS annual meeting provides great opportunities to meet with peers, share perspectives, keep track of industry trends and form successful partnerships.  We still have meeting slots open for T...

The U.S. Food & Drug Administration (FDA) has resumed planning and conducting domestic surveillance inspections across all  commodities.

 #gmp #fda #regulations #fda21cfrpart820

https://www.fda.gov/news-events/press-announcements/fda-roundup-february-4-2022

FDA published proposed changes to 21 CFR part 820 which seeks to harmonize the regulations with ISO 13485.

Public comment is due before May 24, 2022 related to the proposed changes.

Follow link below.

#gmp #fda #regulations #fda21cfrpart820 #iso13485

The AAOS 2022 annual meeting is back on the normal schedule taking place in Chicago, Illinois on March 22 through 26.  Hopefully attendance will be back to normal as well, allowing for more information exchange and networking.

Follow the link below for specific information direct from AAOS.

https://www.aaos.org/annual/

Engineering & Quality Solutions, Inc's president and principal engineer, Victoria Trafka, authored a new article for Orthopedic & Design Technology magazine.  The article is titled "Intelligent Iteration: The Benefits of Prototyping Rapidly" and discusses the benefits and reasons for utilizing quick prototypes during all phases of product design for medical devices.

https://www.odtmag.com/issues/2021-03-01/view_columns/intelligent-iteration-the-benefits-of-prototyping-rapidly/?widget=listSection

If you're performing mechanical or performance testing on your devices, you may want to review this new FDA guidance to make sure that expected information is included in test reports and protocols intended for submissions. Presenting testing in the proper format will make the submission process faster and smoother.

See the link below for the guidance titled "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions":

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-non-clinical-bench-performance-testing-information-premarket

Engineering & Quality Solutions, Inc"s president and principal engineer, Victoria Trafka, authored an article recently published in Orthopedic & Design Technology magazine.  The article is titled "Five Reasons For The Small World Of Orthopedic Product Development" and explores why product development engineers in the orthopedic and spine industry don't often cross over into other areas of medical device.

https://www.odtmag.com/issues/2019-11-01/view_columns/five-reasons-for-the-small-world-of-orthopedic-product-development/

I was pleased to be one several expert presenters at the ASTM Workshop on Medical Device Standards Utilizing Computational Modeling. I discussed a case study of Finite Element Analysis (FEA) of an orthopedic plate. This workshop was sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices and was meant to “bring together thought leaders in the medical device modeling and standardization communities” for education and advancing the use of computational modeling. The agenda had several very interesting presentations and provided a wide range of information relevant to orthopedic and spinal development today. See the link below to view the agenda.

https://www.astm.org/MEETINGS/SYMPOSIAPROGRAMS/F04ID3804.pdf