We, at iMDR MedTech Consultancy, have a proven track record of delivering high quality MedTech projects in a speedy and complaint manner. Right from product design, risk management, dossier compilation to post market surveillance, iMDR has got your back! Reach out to us at [email protected] Learn more: https://lnkd.in/dN79H-fA #MedicalDevices #Consultancy #MDR #Regulatory #Quality
iMDR MedTech
医疗设备
Columbia,Maryland 3,175 位关注者
iMDR is a medical devices consulting firm with a base of 200+ medical devices regulatory experts worldwide #iMDR
关于我们
With the 200+ Medical Devices Regulatory Experts worldwide, iMDR is helping its clients to meet the regulatory requirements and deliver the safe medical devices. We specialize in consulting ISO, IEC, USFDA, ASTM, TGA, CDSCO, ANVISA, PMDA and EU requirements for medical devices. We have experienced team of regulatory compliance auditors situated in countries worldwide USA, India and Australia
- 所属行业
- 医疗设备
- 规模
- 2-10 人
- 总部
- Columbia,Maryland
- 类型
- 私人持股
- 创立
- 2021
- 领域
- Medical devices regulatory、CDSCO consultation、EUMDR、MDR、IVDR、Business consulting和USFDA consulting
地点
iMDR MedTech员工
动态
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Give right direction to your EU MDR compliance journey with iMDR 's best in class gap assessment tools and remediation plans Compliance can’t wait, and neither can patient safety—start your journey with us today! #Compliance #EUMDR #MDR #Compliance
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Quality comes at a cost, but not more than cost of recalls! Process Design, Monitoring and Control are key aspects in ensuring continued quality. iMDR Auditing Services LLC offers a comprehensive, customizable, 21 CFR Part 11 compliant; validated solution for MedTech manufacturers! Reach out to us to learn more! #MedicalDevices #Manufacturing #ProcessOptimization
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UDI serves one of the most important outcomes of the EU MDR, the transparency. iMDR Auditing Services LLC has implemented UDI for multiple organizations of repute! We support with GTIN integration, cloud storage and regulatory filing. Reach out to us to implement UDI for your Medical Device #MedicalDevices #UDI
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Process simplification can yield you faster manufacturing, lower costs and better quality, all at the same time! iMDR Auditing Services LLC has helped 50+ global clients in streamlining the manufacturing by process simplification with 100% compliance. Learn more about Process Simplification this Sunday, 13th October in our exclusive webinar! Reach out to Aakash Jindal to register! #ProcessSimplification #Optimization #MedicalDevices
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Enroll now for ISO 13485 Lead Auditor Certificate course by iMDR Auditing Services Develop strong fundamentals on ISO 13485 and gain auditing skills to assess compliance. Course title: ISO 13485 Lead Auditor Certificate course Course Cost: Rs 14,999 Course Structure: Instructor led 6 sessions, 1 mock audit Reach out to Aakash Jindal to enroll! #MedicalDevices #LeadAuditor #Auditing #Compliance
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We're hiring! Are you passionate about Medical Devices Regulatory Affairs and have experience in Dossier Compilation for Japan market? If yes, you are the right fit for the role! Job role: Sr. Consultant- APAC Medical Devices Regulatory Experience: At least 2 years of experience in Regulatory Affairs for Japan market, with overall experience not less than 5 years. Education: Degree in science or related stream Compensation: Negotiate, no bar for right candidate. Language Requirements: Japanese (JLPT N3 minimum), English (Fluent) PS: Candidates will be working with a Large MNC on third party payroll, based in Mumbai, MH. #Hiring #MedicalDevices #Regulatory #Japan
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Can Lean and Quality go hand in hand? Yes, while it is important to simplify processes and reduce wastages, it is also important to maintain the high quality. With years of expertise, iMDR provides best in class process simplification solutions. #Lean #MedicalDevices #Quality
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Adequate process controls not only ensure the regulatory compliance, but also support operational scrap reduction in manufacturing! iMDR has proven expertise in defining effective process controls for manufacturing value stream #MedicalDevices #Manufacturing
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End to End Digitization of QMS is one of the first steps towards entering the era of technology driven manufacturing! iMDR stands as a strong companion in your journey of digitization; right from Quality Event Management, Digital Batch Manufacturing Logs to Training Automation. #QMS #Digitization #MedicalDevices