Derek Silva’s Post

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Useful video on #PMCF, head over to our #Youtube channel to learn more about #medicaldevice #regulatoryaffairs.

In our latest blog, we explore how medical device regulations are evolving to encompass a broader focus. Beyond just health and safety, these regulations now also emphasize protecting fundamental rights and the environment. Learn about the key changes, their impact on the industry, and how to align your practices with these comprehensive standards. 🔗: https://lnkd.in/eH2s82eB #MatrixRequirements #MedicalDevices #RegulatoryCompliance #Sustainability #HealthcareInnovation #FundamentalRights

𝐓𝐞𝐫𝐦𝐢𝐧𝐨𝐥𝐨𝐠𝐢𝐞𝐬 𝐟𝐨𝐫 𝐂𝐚𝐭𝐞𝐠𝐨𝐫𝐢𝐳𝐞𝐝 𝐀𝐝𝐯𝐞𝐫𝐬𝐞 𝐄𝐯𝐞𝐧𝐭 𝐑𝐞𝐩𝐨𝐫𝐭𝐢𝐧𝐠 (𝐀𝐄𝐑): 𝐭𝐞𝐫𝐦𝐬, 𝐭𝐞𝐫𝐦𝐢𝐧𝐨𝐥𝐨𝐠𝐲 𝐚𝐧𝐝 𝐜𝐨𝐝𝐞𝐬 The International Medical Device Regulators Forum (#IMDRF) has published an update - see link here https://lnkd.in/d9PS4KN5 #adverseevents #mdr #ivdr #regulatorycompliance #medicaldevice

Stay compliant and stress-free in 2024 by understanding the latest medical device regulations. https://wix.to/vNJaIMy #RegulatoryUpdates #MedicalIndustry #MedicalDeviceRegulatory #MedicalDevice #MedicalDeviceManufacturing

We know how tough it can be to navigate the complex and ever-changing world of medical device regulations. At Synergy, we’re here to make the process easier and help you get your medical device to market safely and successfully. Our tailored strategies are designed to minimize your company's risks, streamline compliance, and get your device into the hands of patients who need it. With our help, you can confidently bring your devices to market. Let’s connect today on a market access strategy for your next medical device. #MedicalDevices #RegulatoryCompliance #QualityAssurance

ICYMI: EU medical providers have full access to COBRA-OS®. 🌍 With this groundbreaking aortic occlusion device being granted CE marking under the new EU Medical Device Regulations, COBRA-OS® has transformed how medical providers manage bleeding emergencies. Curious to learn more? Read the full article linked below. ✨ https://lnkd.in/ee6UQQHK #cobraos #medicalinnovation #cemarking #frontlinemedtech #patientcare #aorticocclusion #healthcarerevolution

Procedure Pricing Somewhat counterintuitively, medical procedure price transparency appears to slightly raise prices. Transparency does not impact the quality of service, and most critically and quite troublingly, does not increase consumer price shopping. This result of higher prices is strongest for low-cost providers with low out-of-network spending. This suggests that transparency provides more pricing information to providers, which allows for tacit medical procedure provider collusion.

Understanding Post-Market Surveillance (PMS) is vital for ensuring patient safety and maintaining compliance in the ever-evolving medical device industry. Check out this insightful piece on PMS to explore its significance and how it can empower manufacturers to enhance device performance and build trust. Click the link to read more! #MedicalDevices #PostMarketSurveillance #QMS #RegulatoryAffairs #PatientSafety

Timely Reporting of Medical Device Adverse Events Crucial #Classofmedicaldevice #MateriovigilanceProgrammeofIndia #MateriovigilanceProgrammeofIndia(MvPI) #MDR2017 #Medicaldeviceadverseevents #medicaldevicelicensing #medicaldeviceriskmanagement #MedicalDevices #MvPI #postmarketsurveillance(PMS)