RACS has been renewed as a BTMD Notified Body in Bahrain, authorized to issue EER labels, reinforcing its commitment to energy efficiency and quality compliance. #RACS #EnergyEfficiency #Bahrain #Sustainability #Certification #QualityStandards #EER #NotifiedBody #BTMD

Marine equipment certification (MED) #WheelmarkMarking #AITEX is a #NotifiedBody No. 0161 to certify marine equipment according to Directive 2014/90/UE on fire protection and recognized by the International Maritime Organization (#IMO). More information: aitex.es/marine-equipment-ce…

🔊Marine equipment certification (MED). #WheelmarkMarking🚢 ➡#AITEX is a #NotifiedBody No. 0161 to certify marine equipment according to Directive 2014/90/UE on fire protection and recognized by the International Maritime Organization (#IMO). More info: aitex.es/marine-equipment-ce…

$nnox $nvda In the near future... we completed a five-day audit by the notifiedbody as part of the certification process forthe CE certificates, the ISO 13485 plusmedical device regulations, MDR certificate.

When I became Certified "Manager of #RegulatoryAffairs #Medicaldevices International" In 2014 for 6 months and in parallel to my last semester in Master Degree Program of #BiomedicalEngineering in @fh_muenster in #Germany, I attended and became successfully through this qualification process in Germany and in German language together with German Participants from various medical devices #manufacturers "Manager of Regulatory Affairs Medical Devices International" after we successfully passed the Examination and presented certification case study. Qualifications process held in Cologne under @tuvcom_akademie and @THU_Ulm . The learning outcomes was 360' #medicaldevices knowledge and lifecycle which include but not limited to #Design , #Purchasing, #Manufacturing , #postmarketsurveillance , #ISO13485 #qualitymanagement , #ISO14155 #clinicalevaluation #ClinicalEvidence #Clinicalinvestigation, #ISO14971 #riskmanagement #standards #conformityassessment , #regulations #Compliance #ISO10993 #Biocompatibility #IEC60601 #medicalelectricalequipment #MEE #Essentialprinciples of #Safety & #Performance of #medicaldevices #marketaccess #EU #CE #notifiedbody #MDD #IVDD #FDA #510K #PMA #HealthCanada #TGA #China #Japan

[#Italy] Did you know that Apave in Italy is a European #NotifiedBody for the Directive on the #Safety of Toys (2009/48/EC) ❓ This directive covers all mechanical-physical, flammability, #electrical, hygiene & #chemical requirements relating to #toys 🧸 👉italy.apave.com/en/Contatti

Another essential milestone on our IVDR journey! We are thrilled about the designation of mdc medical device certification GmbH as the 9th EU-IVDR Notified Body. This milestone marks a crucial step forward in the implementation of IVDR. #BIOTYPE #IVDR #NotifiedBody

Class I #MD doesn't need #Notifiedbody involvement for #conformityassessment in the case of non-sterile & non-measuring. Click here: lnkd.in/gAEhXsjT to know the services offer by #RegTrac on class I #medicaldevices. #compliance #EU #UK #PMS #dosanddonts #EUDAMED #PMS #CA

Class-I #Medicaldevices without Sterile/Measuring functions can be #selfcertified by performing #conformityassessment without #NotifiedBody involvement, Find more on CA for C-I MD in post below. Click here to know more about our MD Services lnkd.in/gEkzthbB. #RegTrac #CE

Class IIb implantable devices (WET) involve #NotifiedBody for #conformityassessment. Know detailed information on #CA route in post below. For more information contact us at: lnkd.in/gEkzthbB #RegTrac #MedicalDevices #MDR #WET #EU #CE #cemarking #Marketaccess #implants

Wonderful news for Christmas! There are now 8 Notified Bodies for IVDs. Congratulations QMD Services GmbH on becoming a Notified Body. Link to NANDO Database: lnkd.in/gMBTqn-D #RegTrac #Notifiedbody #IVD #Conformityassessment #regulatoryaffairs #Manufacturers #invitro

Class IIa #MedicalDevices Considered as Medium-risk devices involve NB for #ConformityAssessment, Find out more details on route for CA in the post below. Contact us at lnkd.in/gEkzthbB #RegTrac #EU #EAR #Foreignmanufacturer #Medicaldevicemanufacturer #CE #NotifiedBody

Greg Czumak, Senior Review Engineer of the American Certification Body, has been providing client support to industry icons for decades. #global #certifications #approvals #wireless #ISED #EU #acbcert #CE #marking #MIC #5G #notifiedbody

[Milestone] BSI Netherlands @BSI_NL will be our company’s Notified Body with the objective to certify the Quality System and subsequently obtain the CE marking for the products in development. #FrenchTech #MedTech #Nantes #notifiedbody #Deeptech

Congratulations to @ECMsrl on becoming a #NotifiedBody. The detailed scope is here if you are looking for a #NB. tinyurl.com/3h9mys2j #RegTrac #Medicaldevices #MDTF #conformity #CE #EU #Regulatoryaffairs #IVD #audits #manufacturer

MDCG 2022-14, a new position paper by the #MDCG in an attempt to remedy the issues of #notifiedbody capacity. #CEmarking #medicaldevices #invitrodiagnostics #medtech #EUMDR #EUIVDR #moleculardiagnostics medicaldeviceslegal.com/2022…

GERMAN #NotifiedBody, @tuvcom_presse which issued #CE Certificate for over a decade conducted NO TESTING on #PIPImplants WHATSOEVER. Still in court claiming no harm to #PIPinjured patients. PLEASE @ansm @LV_MPA @RIVM stand up for the rest of the world. SHARE YOUR #PIP DATA

[#Italy] Need to gain access to the markets of the European Union? The #CE marking enables you to do just that! Find out how we can help you obtain the CE marking: ✔️ As a European #NotifiedBody ✔️ Through #conformity assessment procedures 👉 ow.ly/WKs650JvP6A

Learn how to improve your chances of passing #IVDR notified body review by checking out our latest feature in @MDDIonline: hubs.ly/Q01c2gyv0 #RQMplus #IVD #notifiedbody

After being published in 2017, the #IVDR is imminently coming into force on 26 May 2022! 📣🧪 Make sure you are in #compliance and are engaging a #notifiedbody where needed❗