FDA has published several guidance documents related to SaMD, SiMD and connected medical devices that shifts the regulatory landscape for both new and experienced medical device companies. Join experts from MCRA and Innolitics for an overview of these landscape shifts and a panel discussion on the practical implications and applications with experienced regulatory, quality, cybersecurity and software development professionals navigating this every day in the upcoming webinar, “FDA Cybersecurity and Software Policy Updates: Navigating the New FDA Guidance for Medical Devices.” Register now for our webinar! https://lnkd.in/ezK3A3hJ Nikki Batista Alex Cadotte Lauren White, MBA, CISSP Dan Goldstein Innolitics Yujan Shrestha, MD J. David Giese #medicaldevices #medicaldevice #medtech #medicalequipment #fda #regulatoryaffairs #regulatory #cybersecurity #digitalhealth #SaMD #SiMD #quality #QA #qualityassurance #webinar #free #MCRA #innolitics
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Robert A. Herrmann reposted this
MCRA is pleased to announce its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA) to approve the SurVeil™ drug-coated balloon (DCB) to treat peripheral artery disease (PAD). MCRA’s Regulatory and Biocompatibility experts collaborated closely, enabling MCRA to both develop the robust technical discussions and then articulate them to FDA in terms of safety, effectiveness and favorable benefit-risk profile. Read the full press release on our website now. Surmodics, Inc. #mcra #pma #cardiovascular #medtech #biocompatibility #fda #medicaldevices #news
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Robert A. Herrmann reposted this
MCRA delivers #clinicalstudy success stories. #medtech companies across the world trust MCRA for their #clinicalresearch support needs. Our world-class expertise unlocks multiple barriers to success, resulting in improved #clinicaltrial rates and greater client satisfaction. Learn how we can help you advance your medical technology goals. Contact Our CRO Team to Learn More https://lnkd.in/ehwSCmAm
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Robert A. Herrmann reposted this
As CDRH Deputy Ombudsman, I provide a confidential, independent, and impartial resource for preventing conflicts and resolving disputes with and within CDRH. Co-Chair, ABA Ombuds Subcommittee – Ombuds Day is 10/12/2023.
FDA clearance/approval does not equal patient access! Payers Need Clear Outcomes Data to Reimburse Digital Health, Experts Argue It’s clear that services like telehealth and remote patient monitoring have potential to provide value within the healthcare industry, but hospitals and digital health companies need to show payers clearer evidence of the outcomes these care modalities can produce in order to earn reimbursement, panelists argued during MedCity's INVEST conference. https://lnkd.in/d5NcCjGW
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Robert A. Herrmann reposted this
Meet MCRA: Devjani Saha, Director of Neurology Regulatory Affairs Dr. Saha is a biomedical engineer by training with over 6 years of FDA experience and over 10 years of research experience in brain computer interfaces, medical robotics and neurostimulation devices. While working at the FDA, Dr. Saha contributed to the development of the several policies and guidances, including the leapfrog guidance on brain computer interface, policies for the regulation of wearable devices for physical rehabilitation, and standards supporting exoskeleton pre-clinical testing. She also was a policy lead for the Real World Evidence initiative at the FDA and helped to launch the Safer Technologies Program (STeP) and provided programmatic expertise during the review of STeP submissions. Learn more about Dr. Saha and their work on our website: https://lnkd.in/erf5Y9SE #mcra #meetmcra #fda #neuroscience #medicaldevices #regulatoryaffairs #robotics #braincomputerinterface #medicalrobotics #neurostimulation #exoskeleton #medicaldevice #regulatory #regulatoryrequirements #regulatorycompliance
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Robert A. Herrmann reposted this
MCRA is pleased to announce the addition of anesthesia and critical care as a new therapy specialization, led by former FDA Assistant Director Todd Courtney. With the growth in the number of medical devices for anesthesia and critical care, MCRA has hired Mr. Courtney as the Vice President of Anesthesia Regulatory Affairs. Read the full press release on our website now. #mcra #anesthesia #criticalcare #regulatoryaffairs #anesthesiaregulatory #fda #medicaldevice #medicaldevicecro #clinicalresearchorganization #medicaldevices
MCRA Expands into Anesthesia and Critical Care Therapy Specializations, Hires FDA Assistant Director
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