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From : Communities >> Regulatory Open ForumThe short answer is: FMEA is not Risk Management. You should expect to provide the entire Risk Management File. —————————— GertSørensen http://www.quality-audit.eu ——————————

From : Communities >> Regulatory Open ForumDear Annon reach out to confinis ag start-up workshop which fit exactly your request or contact confinis dierectly. confinis ag regulatory compliance and beyond hauptstrasse 16 ch-3186 düdingen http://www.confinis.com info.ch@confinis.com Adrian —————————— Adrian Gammeter senior consultant Düdingen Switzerland ——————————

From : Communities >> Regulatory Open ForumHello Dear Experts, Thanks for sharing your experience. I am looking for Marketing Resume strategy after submission of One time status report. My understanding from the FDA Guidance is, we need to submit a 356h along with a cover letter citing "ADMINISTRATIVE CHANGE / NOTIFICATION OF COMMERCIAL MARKETING", 30 to 60 days ahead to resume marketing. Please comment if you have such experience. —————————— SUJAN BOSE M.Pharm ——————————

From : Communities >> Regulatory Open ForumInteresting graph from a recent survey: https://health.ec.europa.eu/system/files/2023-08/md_nb_survey_certifications_applications_en.pdf —————————— AnaCiric, PhD, RAC-Devices RA/QA Specialist Singapore ——————————

From : Communities >> Regulatory Open ForumDear All, If someone passed their RAC exam, what other qualities do you look for when deciding whether to interview them for a job? Thanks, Vasu —————————— Vasumathy Miduturu Cambridge MA United States ——————————

From : Communities >> Regulatory Open ForumWith over 275 million people, Indonesia is the world's 4th largest country. Healthcare spending is expected to rise from about $35 per person in 2005 to over $270 per person by 2027. On July 11, the Indonesian House of Representatives announced a Health Bill to jumpstart Indonesia's healthcare market. Via the new Health Bill, the government has tried to reduce bureaucratic requirements to make drugs and devices locally. In addition, the Bill now makes it possible for foreign doctors and healthcare [More]

From : Communities >> Regulatory Open ForumDear All, I kindly request your assistance in providing information or sharing your knowledge regarding the following query: Are there guidelines that specify the proper storage area requirements for documents and non-inventory equipment/items in pharmaceutical warehouses? —————————— Akshay Pawar Auditor Quality and Compliance India ——————————

From : Communities >> Regulatory Open ForumDear All, I would appreciate it if you could provide information or share your knowledge regarding the following queries: (1) Can you share any guidelines or best practices related to status labeling within pharmaceutical warehouses? (2) Is there a guideline that outlines the proper segregation of approved, under testing, quarantine, and destruction materials, along with their corresponding status label requirements? (3) Are there any Good Warehouse Practices (GWP) guidelines that provide [More]

From : Communities >> Regulatory Open ForumDear Members, Can anyone share a reliable regulatory guideline reference for effectively handling and investigating shipping discrepancies, such as overages, shortages, and damages (OS&Ds), within the supply chain for finished pharmaceutical products? —————————— Akshay Pawar Auditor Quality and Compliance India ——————————

From : Communities >> Regulatory Open ForumHey Anne Thank you for your reply! —————————— Lulu Zhang PRRC/Management Representative Head of Quality and Regulatory Affairs Canada ——————————

From : Communities >> Regulatory Open ForumHi there! RAPS is looking for members interested in joining our membership committee. The membership committee works with RAPS staff to provide advice, feedback, and counsel on membership recruitment, retention, engagement, inclusion, and membership value through recognized program benefits, educational offerings, networking opportunities, and other services to ensure that the member experience meets expectations and provides value to assist regulatory professionals. —————————— [More]

From : Communities >> Regulatory Open ForumHi Anon The 2002 Regulation adopted them as-is. https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#legislation-that-applies-in-great-britain —————————— Anne LeBlanc United States ——————————

From : Communities >> Regulatory Open ForumHi Lulu Yes, if this company doesn't have a copy of the CE certificate and related information in the files, the NB should be able to help. Some of the NBs also have relevant information online, which can be handy. For example, TÜV Rheinland's "Certipedia": https://www.certipedia.com/ https://www.certipedia.com/certificates/69244207?locale=en You may also want to check if this new company has written an appropriate procedure for record keeping already. —————————— Anne [More]

From : Communities >> Regulatory Open ForumDear Pravin, Thank you for your reply. This is what I would have assumed, yet our experience with close to 10 Type D meetings is that all have been WROs, so I began to question if this was the default for Type D meetings. I greatly appreciate your perspective from both sides of the aisle. I will update this post if we are granted a TC for a Type D meeting. Thanks again, Monique —————————— Monique Franc Scientific Director North America Regulatory Lead – Neuroscience [More]

From : Communities >> Regulatory Open ForumThank you, much appreciated 🙏 [More]

From : Communities >> Regulatory Open ForumThis message was posted by a user wishing to remain anonymous Hi Community, What are the FDA's expectations with respect to the Risk Management File (plan, analysis, report) in submissions such as 510(k) and IDE? We have a software-based mechanical medical device, and we know that FDA expects to see at least the sFMEA in the software section. But do they want to see the entire file? In case you file only the software portion, how do you keep the traceability between the submitted sFMEA document [More]

From : Communities >> Regulatory Open ForumThis message was posted by a user wishing to remain anonymous Hello everyone, My question is quite simple. What site/vendor would you recommend a start-up to purchase good quality QMS templates. We are looking for ISO13485:2016 (A1:2021), EU and Canadian MDR templates too. Thank you

From : Communities >> Regulatory Open ForumThis message was posted by a user wishing to remain anonymous Hi forum, Does UKCA marking have essential requirements different from the MDD ? Thanks

From : Communities >> Regulatory Open ForumThis message was posted by a user wishing to remain anonymous I would doubt that the FDA would take a minimalistic approach. Since there is a laser involved, the safety concerns will be there and hence demonstrating conformity to basic safety, EMC, laser power/classification, etc. will apply. Being a quantitative device, the linearity over flow rates, blood vessel size vessel/blood flow direction, etc. will have to be proven. Usability could come into play if the blood flow reported is indeed dependent [More]

From : Communities >> Regulatory Open ForumDear colleagues, hello! On a monthly basis, I compile a list of De Novos, PMAs (original), 510ks, warning letters and recalls. You will find a brief summary of each and links to relevant resources. This can save you a lot of time in your own research! Click on this image below for the August 2023 summary. As an example, here is a quick summary of 510Ks Access the full report here. Hope you will find it useful! —————————— Naveen Agarwal, Ph.D. Problem Solver | Knowledge [More]