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@makrocareposts
MakroCare offers Life cycle maintenance service for medical device manufactures & end users, To maintain quality and compliance of device throughout the life cycle.
MakroCareâs Lifecycle group partners with manufacturers in supporting their legacy/matured products doing Regulatory, Post-market surveillance, Safety, Clinical and Medical Affairs activities
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In Vitro Diagnostic Regulation Consulting Services
Medical Device Regulatory & Clinical Experts for new EU Medical Device Regulation. Our Experts guide your teams for a smooth transition from MDD to MDR & stay compliant. Learn more about our timely solutions today.
MakroCare covers the entire spectrum of Regulatory support services for medical devices in order to market products in these stringently regulated countries
MakroCare develops and implement methods for efficient Post-Market Surveillance for you, which is in accordance with Regulations and Directives of Medical Devices
MakroCare is a leading services provider supporting software based devices and diagnostics.Either as full service end-to-end or functional services, we partner with companies in supporting medical device software including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD) and Accessories to medical devices composed of software.for more info visit: https://www.makrocare.com/devices/software-as-medical-device
MakroCare is a leading services provider supporting software based devices and diagnostics. Software in medical devices, medical device software development, Medical device software Challenges, software medical device fda guidance, software as medical device guidance fdaÂ
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According to the International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD)is defined as âsoftware intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical deviceâ.
MakroCareâs Global Medical Device Labeling team provides advisory and implementation services to ensure your compliance maintained at all times, whether itâs local country labels or compliance (EU) 2017/745.
Makro Care offers end to end labeling services for medical devices , We done all artwork , packing , gap analysis works for medical devices
MakroCare offers Post Market Clinical Follow-up (PMCF) services , it is one element of PMS activities which can confirm the clinical performance and safety of the device .
The EU In Vitro Diagnostic Regulation (IVDR) implementation debates starting ahead of the GAP assessments. MakroCare Experts guide you how to go about doing a systematic review of your technical documentation and QMS.
MakroCare IVDR consulting services will helps you to clear the IVDR transition & compliance issues to place your ivd devices in market.
Medical Device Regulatory & Clinical Experts for new EU Medical Device Regulation. Our Experts guide your teams for a smooth transition from MDD to MDR & stay compliant. Learn more about our timely solutions today.
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PMS is a collection of processes and activities used to monitor the performance of a medical device. These activities are designed to generate information regarding use of the device to expediently identify device design and/or usage problems and accurately characterize the real-world device behaviour and clinical outcomes.
Post-Market Surveillance of Medical Devices
PMS is a collection of processes and activities used to monitor the performance of a medical device. These activities are designed to generate information regarding use of the device to expediently identify device design and/or usage problems and accurately characterise the real-world device behaviour and clinical outcomes
EU MDRÂ Compliance & Transition services MakroCare
The new EU Medical device regulations affects on medical device  companies & manufactures.  MakroCare  team experts in Providing EU MDR & CE Marking services.
Clinical evaluation Report (CER )Â is necessary for market a product in Europe. This CER report includes analysis of clinical data, safety and performance of product. Â