MEDVACON TALENT ACQUISITION, LLC ’s Post

𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐢𝐧 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 The regulatory framework for medical devices is multi-faceted, with regulations varying across different regions. In the United States, the FDA serves as the regulatory authority, governing medical devices under the Federal Food, Drug, and Cosmetic Act. 𝐑𝐞𝐚𝐝 𝐌𝐨𝐫𝐞: https://cutt.ly/Qw3bymm4 #MedicalDevices #RegulatoryCompliance #HealthcareRegulations #MedTech #ManufacturingCompliance #FDARegulations #QualityControl #HealthcareEverything #BestHealthcareDigitalMagazine #TopHealthandWellnessMagazines

Making sure vital medical information is never lost in translation✨🌍🩺. ☑️ Medical Reports ☑️ Patient Medical Records ☑️ Doctor’s Prescriptions ☑️ Informed Consent Forms ☑️ Clinical Trial Documents ☑️ Pharmaceutical Documents ☑️ Medical Device Manuals ☑️ Insurance Documents ☑️ Patient Education Materials ☑️ Legal Documents #TranslationMatters#GlobalHealthcare#MedicalLanguageExperts#BizpointTranslations #GlobalCommunication #MultilingualSolutions #TranslationPartner #DubaiBusiness #120Languages

FDA Classification The FDA (Food and Drug Administration) classifies medical devices into three classes based on the level of control necessary to ensure the safety and effectiveness of the device. The classification of your device defines the type of Premarket Submission necessary for FDA approval to market the device in the U.S. For devices classified as Class I or II that are not exempt, a 510(k) submission will be required for marketing. For devices classified as Class III a PMA will be required. For each Class the FDA determines different regulatory control. 🔹 General controls are regulatory requirements authorized by the FD&C Act, under sections 501, 502, 510, 516, 518, 519, and 520. 🔹Special controls shall include: Performance standards, Postmarket surveillance, Patient registries, Special labeling requirements, Premarket data requirements and Guidelines. At OLKON, we can navigate you through all the classification processes and ensure it meets all regulatory requirements! If you need more information about this topic you can contact us via sales@olkon.tech. #OLKON #Medicaldevices #FDA

Excited to share insights from the FDA's latest article on premarket submissions! In this article you can learn more about the critical topic of "Fraudulent and Unreliable Laboratory Testing Data" and its impact on the medical device industry. It also addresses key takeaways and recommendations for ensuring data integrity in regulatory submissions. Don't miss out on this essential read for professionals in the medical device sector! #FDA #MedicalDevices #RegulatoryCompliance

Choosing a trustworthy test lab from the start ensures your product has accurate data that meets the FDA’s integrity requirements. MCRA's Biocompatibility experts understand the nuances of selecting a lab who you can trust. Let us help you vet test labs to find the best fit for your project. Our target is your success. Reach out to MCRA today: https://lnkd.in/ezA5zGxa https://lnkd.in/gNFTaMk9 #MCRA #biocompatibility FDA #fdacompliance #fdaregulations #fdaapproval #fda #medtech #medtechindustry #medicaldevices #medicaldeviceindustry #medicaldeviceregulation #regulatorycompliance #regulatoryaffairs #regulatory #biocompatibilitytesting #testinglab #testinglaboratory #medtechexperts

It is critical to work with a testing partner with a excellent quality management system so you can trust the results.

Every prescription, diagnosis, and report translated with care and expertise. 🩻🌐 ☑️ Medical Reports ☑️ Patient Medical Records ☑️ Doctor’s Prescriptions ☑️ Informed Consent Forms ☑️ Clinical Trial Documents ☑️ Pharmaceutical Documents ☑️ Medical Device Manuals ☑️ Insurance Documents ☑️ Patient Education Materials ☑️ Legal Documents #TranslationMatters#GlobalHealthcare#MedicalLanguageExperts#BizpointTranslations #GlobalCommunication #MultilingualSolutions #TranslationPartner #DubaiBusiness #120Languages#MedicalTranslation #HealthTranslationExperts #HealthcareInEveryLanguage"

In 2022, Food and Drug Administration proposed a rule amending current good manufacturing practice (cGMP) requirements for medical devices under the Quality System regulation. The intent of the proposed rule is to align FDA's regulatory framework with that of other global regulatory authorities, promote consistency in the regulation of medical devices, and enable the timely introduction of safe, effective, high-quality devices to market. Once finalized, the proposed rule will have significant impacts on risk management practices for medical device manufacturers per ISO 13845 such as supplier selection; staff training on risk management procedures; developing procedures that incorporate ISO 13485; and tracking, trending, and reporting risk management activities.    Join Ryan Siskey, MS of Exponent’s Biomedical Engineering and Sciences Group and Christopher M. Mikson, MD, JD of DLA Piper, as they discuss the current landscape of regulatory requirements, the timing of expected changes, and the challenges manufacturers can expect in meeting the new requirements. Register now at https://lnkd.in/eQhdEuFc

Proud to share that I've earned my certification in US FDA Medical Device Submissions. Looking forward to navigating the complex regulatory landscape and ensuring patient safety. #FDA #MedicalDevice #Certification #RegulatoryAffairs #BiomedicalEngineering #Pharma #Healthcare #LifeSciences #RegulatoryScience #ClinicalTrials #DrugDevelopment