Rakesh Dahiya’s Post

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

Problems, Impact, and Solution for Indian Medical Device Rules (IMDR) 2017 #imdr2017 #problems #Impact #solution

If you're headed to Chicago for the American Medical Device Summit, be sure to stop by Battelle booth No. 54 to chat with Shalene Thomas about how #PFAS regulations are impacting the #medicaldevice industry and what you need to know. Not able to attend? Register for our upcoming webinar "PFAS in Medical Devices: Ask An Expert". https://okt.to/8laCSi #MedDeviceUS24 #GenerisAMD #MedicalDevices #MedicalDeviceSolutions

Current List of Harmonized Standards medical devices and IVDs: Last Updated on: 09. Nov 2024 New harmonized standard for MDR: ✅ 26 out of 226 standards harmonized (11.5%) New harmonized standards for IVDR: Decision ✅ 15 out of 45 standards harmonized (33.3%) https://wix.to/GoVrT68 #harmonisedstandardsmedicaldevices #harmonizedstandardsmedicaldevices #listofharmonizedstandardsmedicaldevices #harmonisedstandardsivds #harmonizedstandardsivds

In the Open FDA medical device reports I've been scanning that contain the term 'algorithm' and either 'diagnosis' or 'diagnostic', I came across one report about a defibrillator device not indicating 'shock advised' for a patient. As I read along the manufacturer: "reviewed the downloaded electronic patient record of the reported event, and it was observed that the presence of ecg artifact was the primary reason for the "no shock advised" decisions in the three analyses in question. I wondered what an ECG artifact was and found this very interesting paper. It seems to outline factors that can distort baseline and wave interpretations. #ecg #analyses https://lnkd.in/e_6ywN_x.

Learn in our whitepaper about the optimal approach to integrating fluid and pneumatic components and systems into medical equipment so that products can meet the strict requirements of the new Medical Device Regulation. https://ow.ly/sjO330sBaV5 #MedicalDeviceRegulation #MDR #MedicalSolutions

Understanding the Medical Device Technical File | Structure of Technical File under the Medical Device Regulation (MDR) Check the full article: https://lnkd.in/gBCF2nes

Check out my our blog post about "How to Ensure Comprehensive Data Collection for Medical Device Safety" https://wix.to/mVUkk1k #newblogpost #Datacreds #Crypta #DrugSafetyDatabase

Learn in our whitepaper about the optimal approach to integrating fluid and pneumatic components and systems into medical equipment so that products can meet the strict requirements of the new Medical Device Regulation. http://emr.as/Nb9x50R1RwC #MedicalDeviceRegulation #MDR #MedicalSolutions

Learn in our whitepaper about the optimal approach to integrating fluid and pneumatic components and systems into medical equipment so that products can meet the strict requirements of the new Medical Device Regulation. https://ow.ly/CYBz30sB1gH #MedicalDeviceRegulation #MDR #MedicalSolutions