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

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 source of 483 letters in the medical device industry, and we’ve helped many clients remediate their DHFs and update procedures to ensure future design control compliance.

DHF deficiencies may be related to products which have been on the market a long time and the documentation practices from many years ago just aren’t sufficient today. In new development projects some personnel or comapnies simply don’t have the expertise, capacity or procedures in place to fully comply with regulations. If a company has identified DHF deficiencies, they may be dedicating resources to remediating DHFs for existing products, reviewing current in-process development efforts more carefully, and revamping design controls procedures to make sure design files are compliant. The internal effect of the DHF remediation effort is a slowing of new development as resources attend to legacy products, improve their documentation and answer corrective actions.

It may seem somewhat painful to go through, but the ultimate effect of strong DHFs (and also the intended effect of the regulations) is a better product with fewer problems. Applying proper design controls helps ensure that the product does what is intended, is safer, is more reliable and predictable, has fewer problems, and meets market needs.

If you need expert help to get your DHFs remediated quickly and efficiently, and to free up internal resources, call us today!

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 appreciated the opportunity to give my experience and perspective.  Check out the full article at this link:

https://www.odtmag.com/issues/2019-08-14/view_features/designing-complexity-simply/

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 consulting on product development, quality systems, manufacturing and transitioning to internal resources if needed. We consult on-site or remotely and can work in a small or large capacity, as company inside resources or outside consultants, whatever works for your company model and stage. Many start-ups operate entirely in the cloud with resources living in different states, and this is a great model to reduce overhead and attract the best personnel. As the company and business evolves and grows, we adapt and provide the resources you need at the exact time you need them!

When business grows and matures, start-ups may decide to remain remote and cloud-based or to transition to a central office. The consultants at Engineering & Quality Solutions, Inc. have worked with all sizes and stages of medical device companies and we understand how businesses function at different stages. We can help streamline transitions by managing growth phases, training new employees, and continuing to support your company as needed.

We can help with:

• Transitioning from External to Internal Resources
• Training New Employees
• Continued Support for Product Development, Quality System and Manufacturing as needed

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 development, quality systems, manufacturing and transitioning to internal resources if needed. We consult on-site or remotely and can work in a small or large capacity, as company inside resources or outside consultants, whatever works for your company model and stage. Many start-ups operate entirely in the cloud with resources living in different states, and this is a great model to reduce overhead and attract the best personnel. As the company and business evolves and grows, we adapt and provide the resources you need at the exact time you need them!

Once the device is designed, product manufacturing needs to be addressed. Many medical device start-ups need help finding manufacturing resources and ensuring they’re qualified to work on medical products. The consultants at Engineering & Quality Solutions, Inc. have worked in medical device manufacturing and quality assurance and we have a network of qualified resources. We’ve toured, evaluated and audited many contract manufacturers, so we can efficiently identify and qualify vendors for your new products. We can act as your resource to manage all aspects of contract manufacturing.

We can help with:

• Identifying and Qualifying Suppliers
• Maintaining Supplier Documentation
• Supplier and Incoming Product Inspection
• Quotes and Proposals
• Manufacturing Technical Problem Solving
• Purchasing Controls
• Supplier Quality Audits
• Acting as Manufacturing & Supply Chain Manager

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 product development, quality systems, manufacturing and transitioning to internal resources if needed. We consult on-site or remotely and can work in a small or large capacity, as company inside resources or outside consultants, whatever works for your company model and stage. Many start-ups operate entirely in the cloud with resources living in different states, and this is a great model to reduce overhead and attract the best personnel. As the company and business evolves and grows, we adapt and provide the resources you need at the exact time you need them!

Once a medical device start-up has completed the concept and is conducting final product development, it’s time to start implementing a quality system. This will help ensure activities are completed in compliance with FDA 21 CFR 820 and the company is poised to move to manufacturing and distribution as soon as possible. The consultants at Engineering & Quality Solutions, Inc. have developed, implemented, and streamlined dozens of quality management systems for start-ups. We know the regulations and we have worked in the trenches ourselves, so we can implement a system which is compliant and functional without being cumbersome. We’ve also been through many FDA inspections and helped companies recover from FDA warning letters.

We can help with:

• Developing a Complete Quality System
• Updating, Finishing or Streamlining an Existing Quality System
• Conducting Internal Audits
• Maintaining QMS Records
• Acting as Quality Manager
• Preparation and Representation for FDA Inspections

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 development, quality systems, manufacturing and transitioning to internal resources if needed. We consult on-site or remotely and can work in a small or large capacity, as company inside resources or outside consultants, whatever works for your company model and stage. Many start-ups operate entirely in the cloud with resources living in different states, and this is a great model to reduce overhead and attract the best personnel. As the company and business evolves and grows, we adapt and provide the resources you need at the exact time you need them!

New business ventures and start-up companies need concepts and products developed quickly and efficiently, which means experienced engineers with the right tools are a must. The consultants at Engineering & Quality Solutions, Inc. have decades of medical device development experience and have the software, instruments and resources to produce concepts and designs in very short timeframes. We can source prototypes and make design modifications in just days, keeping your projects on track.

Most medical devices need an accompanying design history file with appropriate design controls. Our engineers know the FDA regulations and can create the necessary design files for you. Therefore, your product will be designed and the documentation will be compliant with FDA 21 CFR 820.

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 still needs to be a good fit for both sides. The truth is, it’s best to use the same screening and evaluation process for a consultant as you would for an employee.  Here are four key tips to success when working with a consultant.

Interview

Always interview a consultant as you would a prospective employee. Consultants are not employees, but they ultimately work for you!  Therefore it’s best to conduct a thorough interview and find out about their technical qualifications, work experience and communications style.

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