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 standards. If your company falls into either of these categories, Engineering & Quality Solutions, Inc. can help. We can complete your internal auditing and give you real, useful feedback. We understand the latest regulations and standards and how to apply them efficiently. Contact us today to discuss your internal audits.
Engineering & Quality Solutions will be attending the 2018 AAOS annual meeting in New Orleans, LA. This will be EQS's fifth year attending the AAOS annual meeting and we always look forward to meeting with our current and prospective clients.
The AAOS annual meeting also provides great opportunities to see the latest industry trends, share perspectives and form successful partnerships. Please contact us to set up a time to meet in person and discuss how we can help you attain your medical device product development goals in 2018 and beyond!
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 years ago and are in need of an update. Many companies are faced with audit findings and corrective actions related to insufficient DHF procedures and files, and they don’t know where to begin the improvement process. No matter what the scenario is, EQS can help get your DHFs and procedures in order.
EQS can ease your DHF burden by:
- Creating DHFs for new products
- Reviewing & updating existing DHF documents to meet current regulations
- Updating & expanding DHF documents for line extensions
- Updating QMS procedures to streamline DHF processes and meet regulations
- Training employees on understanding DHF documentation and regulations FDA 21 CFR 820.30
Contact us today to discuss your project!
Our goal is to help you meet yours.
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 some of the issues and solutions.
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:
Engineering & Quality Solutions will be attending the 2017 AAOS annual meeting March 14 – 17 in San Diego, CA. This will be EQS's fourth year attending the AAOS annual meeting and we look forward to meeting with our current and prospective clients.
The AAOS annual meeting also provides great opportunities to meet with peers, share perspectives and form successful partnerships. 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 goals in 2017 and beyond!
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 sooner revenues begin rolling in. And some products have a specific launch window where introduction time is critical to realizing sales and gaining market share. But medical device product development takes time, especially for orthopedic and spine devices where design controls and FDA regulations are non-negotiable. So what can you do to launch sooner while maintaining quality on critical projects? Check out these four tips to reduce medical device product development timelines:1) Reduce distractions and multi-tasking
If development team members work on multiple projects and sustaining engineering tasks, consider removing these other duties and allowing team members to work on only the high impact project. They will be more productive and efficient and tasks will be completed faster.
2) Identify and work on the critical design first
Orthopedic and spinal device systems typically contain many implant versions with multiple sizes, geometries and options. If you can identify the worst case version early and design that size first, you can get to prototyping and testing sooner. Then design the remaining versions after the critical one is completed.
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 little smart management. Here are the top four tips we at Engineering & Quality Solutions, Inc. have found ensure success between you and your design firm. These tips hold true whether you’re outsourcing a full project from start to finish or getting outside help with certain portions of the project.
1) Select resources with experience and skill that match your project
For medical device companies, engaging a PD resource who knows the industry is critical. Medical device projects require different considerations such as raw material specs, cleaning & sterilization, testing, submission considerations, design history file creation and FDA regulations. Make sure your design partner understands these requirements in order to avoid delays and design revisions due to missed requirements.
2) Start with detailed project plans with inputs and outputs
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-development-click-to-open-close. If you're interested in getting cost estimates for your specific project, please contact us and we'll be happy to help you!
"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're also glad to see that more MedDev companies are applying these principles, as it helps everyone succeed and ultimately leades to better outcomes and lower costs. Please see the whole article at the link below.
Engineering & Quality Solutions, Inc. will be attending the 2016 NASS annual meeting Oct. 27 – 28 in Boston. We’re looking forward to reconnecting with spine industry colleagues and learning about technical trends in spinal surgery and treatment. Please contact us to set up a time to meet in person and discuss how we can help you meet your development goals!
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 been made to the recommendations. So if you're unsure how changes affect your device status, make sure to revew the guidance documents. See the recent press release from the FDA about this topic at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm515174.htm
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. The FDA has been researching and following the developments in additive manufacturing and now they’ve released draft guidance which covers many relevant topics including manufacturing and processing, cleaning and sterilization, testing, and more. This document titled “Technical Considerations for Additive Manufactured Devices - Draft Guidance for Industry and Food and Drug Administration Staff” is available to the public at the link below.
If your team needs assistance with a medical device project involving additive manufacturing, don’t hesitate to contact Engineering & Quality Solutions, Inc. We have experience with 3D printing applications for orthopedic devices and can help you understand the unique requirements of using this technology.
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. If you have training needs like these or other similar topics, contact us to find out how we can help you.
I'm very excited to be presenting and learning from the many other presenters at the ASTM WORKSHOP ON ADDITIVE MANUFACTURING FOR MEDICAL APPLICATIONS in San Antonio, TX in May 2016. This workshop is sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices. Additive manufacturing can potentially offer the orthopedic industry advantages not previously available but there’s still a lot to be learned in this field. So, it's great to see industry experts sharing their knowledge to further the advancement of technology and innovation in orthopedic applications. Engineering & Quality Solutions, Inc. will be presenting independent research that was conducted in partnership with Empirical Testing Corp.
I really enjoyed giving my perspective on R&D in the orthopedic industry for this ODT Magazine article. The state of R&D in medical devices has changed over the past few years, but exciting things are still happening! Please find the article "R&D Outlook" at the link below.
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 & services, and other factors. The link below to the FDA website provides guidelines on this sometimes complex subject. If you’re wondering about FDA registration and device listing for your company, feel free to contact us and we can help you determine the best path.
Engineering & Quality Solutions will be attending the 2016 AAOS annual meeting March 1 – 5 in Orlando, FL. We have always found this meeting to be exciting and informative, giving everyone a glimpse of new products and of the overall direction of the orthopedic industry.
The meeting also provides great opportunities to meet peers, share perspectives and form successful partnerships. Please contact us to set up a time to meet in person and discuss how we can help you meet your development goals in 2016 and beyond!