Regulatory Mark is obsessed with medical device development. We offer regulatory and quality solutions to expedite your product’s path to market.
Cincinnati, OH
Joined August 2018
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Cybersecurity threats can lead to recalls. Make sure your cybersecurity plan is appropriate throughout your product lifecycle!
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Is your CBD product a drug, cosmetic, or nutritional supplement? It may be depending on your claims; make sure they’re in alignment with FDA regulation! buff.ly/2X3ouP7
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The National Evaluation System for health Technology (NEST) works to more efficiently generate better evidence for medical device evaluation and regulatory decision-making.
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Cincinnati is Home to a Robust Life Sciences Ecosystem, new article on great companies like @GenetesisInc, @eccrinesystems, CinCor, Aerpio, @GeneSight, & @BexionPharma. Thank you, @biospace, for the mention! biospace.com/article/cincinn… #Cincinnati #startups
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FDA’s Pre-Cert Program Enters its Testing Phase - tinyurl.com/y6c7mezq
Quality control and supplier audits done correctly save time and money in the long run. Make sure your QMS has the right processes in place to stop problems before they start! wsj.com/articles/spacex-rock…
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Problems with surgical staplers that came to light last month are now being addressed by the @US_FDA, the agency said.
bit.ly/2ISTbhZ
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An FDA scooplet: The agency has got a new director for it's Office of Regulatory Policy, and its Pew's Elizabeth Jungman. That's a powerful office perhaps best known for its role regulating compounding. More here for Plus subs:
statnews.com/2019/04/24/fda-…
New to medical device industry? Are you a founder who needs a basic understanding of regulatory? Attend the Regulatory Education for Industry (REdI) Annual Conference May 29-30, 2019 #FDA #cdrh #medicaldevice fda.gov/Drugs/DevelopmentApp…
Press Announcements > FDA permits marketing of first medical device for treatment of ADHD fda.gov/NewsEvents/Newsroom/…
Thanks @ODTmagazine for the in depth exploration of orthopedic tech. It was such a pleasure connecting with colleagues and discussing regulatory considerations in software!
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FDA Announces 5/16 Meeting on Responsible Innovation in Dietary Supplements - tinyurl.com/y37yr7w4
Regulatory Mark is looking to hire! If you have medical device regulatory experience DM us or email us at [email protected]. We hope to hear from you soon!
Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions fda.gov/NewsEvents/Newsroom/…
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There's widespread frustration over the progress in #notifiedbody designations. TEAM-NB warns that it won't be able to assess all applications before the 2020 #MDR deadline. #Medtech Europe says that members are prepared, but the #regulatory system is not. bit.ly/2CjU6E2
We regularly direct clients who want to learn more on their own to CDRH Learn - a great tool to learn FDA basics - check it out! #fda #Medicaldevices fda.gov/Training/CDRHLearn/d…
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No longer artificial – AI in Pharma and Healthcare #pharma #health #healthcare #pharmaceutical #medtech #healthtech #Sales #marketing #tech
pharmaphorum.com/views-and-a…