Opus Regulatory Inc.’s Post

Knowing some companies align significant regulatory activities with their fiscal year, which often starts in January, we thought we'd reshare our conversation with Trey Thorsen, MS, RAC, on some of the most frequently asked questions about navigating the 510(k) premarket notification process. Watch our full conversation: https://lnkd.in/gbHfWcJT We tackled questions like: • "I would like to distribute a manufacturer's product under my own company name. Do I need to submit a 510(k)?" • "Can foreign companies submit a 510(k)? • "Besides the fees for paying a consultant to help me put this together, are there any other fees I should be aware of? • "How much does a U.S. Agent typically cost?" • "Do I need to register my facility before I submit a 510(k)?" • "Do I need to provide documentation that my facility complies with the quality system in my 510(k)?" • "Do I need to have my facility inspected to the Quality System Regulations before I submit a 510(k)?" ——— Need expert 510(k) support now or in the near future? Our deep bench of regulatory affairs talent has extensive experience and knowledge, with some having worked directly with and within the FDA. We carefully deploy time-tested best practices during each step of the regulatory process, helping you maximize the likelihood of obtaining market clearance without delay. Our typical 510(k) support engagement follows a 4-phase structure: 1. Gathering detailed information about your company's project and expectations from the 510(k) process, along with defining the scope of work, objectives, timelines, and responsibilities to ensure a successful partnership. 2. We conduct an in-depth analysis of your medical device, including its intended use and potential predicate devices, to determine its FDA classification. This phase also involves identifying specific requirements for the 510(k) submission and preparing a comprehensive Regulatory Advisory Letter (RAL) that outlines all necessary documents for the application. 3. We emphasize the importance of pre-submission evaluations, particularly in cases with no clear predicate devices or uncertain testing requirements. This includes collaborative preparation for FDA feedback and aligning with FDA expectations to streamline the submission process. 4. Finally, Phase 4 involves a thorough review of all documents provided by your company to ensure compliance with FDA standards, drafting the 510(k) application, and navigating the submission and review process, which typically takes about 3 to 4 months, although this timeline can vary. Get in touch with us to learn more about how we can help you navigate the 510(k) submission process quickly and efficiently and move your product to market. #fda #510k

Will you be heading to DIA’s Global Labeling Conference? As experts in local and global product labeling, we can’t wait to share our insights with industry and regulatory peers. Make sure you visit our experts at Booth 2 to see a demo and learn more! https://bit.ly/3OyRl6K #regulatorylabeling

Next Destination: #RAPSEuroConvergence Together with my colleague Christiane Reinwald we are about to start our journey to Berlin. We are more than excited for the next 3 days of learning and getting in touch with everyone who shares our passion for regulatory affairs. Stay tuned as we share updates and insights straight from the conference! #RAPSConvergenceBerlin #RegulatoryAffairs

Calling all Regulatory Affairs Professionals Society (RAPS) members! 📣 Join our regulatory experts in RAPS' Regulatory Exchange for a Q&A session all about UDI. Bring your questions about labeling requirements, GUDID, EUDAMED implementation, and anything else related to UDI, and register here: https://hubs.li/Q02r1XpZ0. Hope to see you there! #UDI #uniquedeviceidentification #regulatoryaffairs

Did you know the FDA released a guide to help farms and facilities comply with changes to the Produce Safety Rule? Smaller companies may have a difficult time complying with these complex regulatory requirements. RSM advisors offer next steps on how to ensure you are compliant. https://rsm.buzz/482NcAt

Did you know the FDA released a guide to help farms and facilities comply with changes to the Produce Safety Rule? Smaller companies may have a difficult time complying with these complex regulatory requirements. RSM advisors offer next steps on how to ensure you are compliant. https://rsm.buzz/4dJV0Z3

I'm really enjoying creating these videos highlighting our experienced regulatory team at MedEnvoy Global! Follow our page and YouTube channel as we'll be featuring even more members from our diverse and experienced professionals. They have alot of interesting knowledge to share. 😀 #medicaldevicelabeling #regulatorycompliance #medenvoyglobal

Did you know the FDA released a guide to help farms and facilities comply with changes to the Produce Safety Rule? Smaller companies may have a difficult time complying with these complex regulatory requirements. RSM advisors offer next steps on how to ensure you are compliant. https://rsm.buzz/3XYBvWX

The FDA released a guide to help farms and facilities comply with changes to the Produce Safety Rule. If you have need help complying with these complex regulatory requirements, RSM advisors can help. https://rsm.buzz/3XWVeXe

When registering your product in the Netherlands, you must understand the laws that apply to your product and comply with several Dutch and EU standards and regulations to avoid a product recall or regulatory penalties. Download our free fact sheet on product registration in the Netherlands through the link in the comment section. #productregistration #Netherlands #EU #productsafety #freeresource #operationalcompanies #BolderGroup #BolderLaunch #BGALaw