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Regulatory Authorized Representative for Medical Device - FDA
As a Regulatory Authorized Representative for Medical Devices operating under the purview of the U.S. Food and Drug Administration (FDA), we at [Company Name] offer expert assistance to medical device manufacturers seeking market entry and compliance within the United States. Our role as your... -
Medical Device Registrations & Dossiers - MakroCare
MakroCare specializes in Medical Device Registrations & Dossiers, providing comprehensive regulatory support to medical device manufacturers worldwide. With the global regulatory landscape constantly evolving, our expert team ensures smooth and efficient navigation of the registration process... -
CDISC Standard for Exchange of Nonclinical Data (SEND) - MakroCare
MakroCare provides expertise in the CDISC Standard for Exchange of Nonclinical Data (SEND), offering comprehensive solutions to pharmaceutical, biotechnology, and medical device companies. As the industry embraces standardized data formats to enhance regulatory submissions and streamline data... -
Global Regulatory Labeling Services - MakroCare
MakroCare offers comprehensive Global Regulatory Labeling Services designed to assist pharmaceutical, biotechnology, and medical device companies in meeting stringent regulatory requirements across global markets. As regulatory standards evolve and market dynamics change, our expert team... -
Global Regulatory Publishing and eCTD submission Services - MakroCare
MakroCare offers comprehensive Global Regulatory Publishing and eCTD Submission Services tailored to meet the diverse needs of pharmaceutical, biotechnology, and medical device companies worldwide. With the ever-evolving regulatory landscape and expanding global markets, our expert team ensures... -
In Vitro Diagnostic Regulation (IVDR) Consulting Services
Our In Vitro Diagnostic Regulation (IVDR) Consulting Services offer comprehensive expertise in navigating the intricate landscape of regulatory compliance within the diagnostics industry. With the European Union's stringent IVDR requirements setting new benchmarks for safety and efficacy, our... -
Medical Device Usability Testing Services - MakroCare
MakroCare offers specialized Medical Device Usability Testing Services aimed at ensuring the safety, effectiveness, and user satisfaction of medical devices. Our comprehensive testing solutions are designed to meet regulatory requirements and enhance the usability and performance of medical... -
Scientific Literature Services - MakroCare
Scientific Literature Services offers comprehensive support for researchers, academics, and professionals in accessing, managing, and utilizing scientific literature. These services encompass various activities, including literature searches, database access, reference management, and... -
Post Market Clinical Follow Up (PMCF) Consulting - MakroCare
Post Marketing Clinical Follow-up (PMCF) is a vital phase in the life cycle of medical devices and pharmaceutical products. It involves the collection of real-world data after a product has been authorized for market use, allowing for continued assessment of safety and efficacy in diverse... -
Performance Evaluation Report (PER) | IVDR PER - MakroCare
Explore MakroCare's specialized Performance Evaluation Reports (PERs) designed to assess the safety and performance of your medical devices. With a dedicated focus on regulatory compliance and quality assurance, our experienced team conducts comprehensive evaluations to ensure your device meets... -
Clinical Evaluation Report (CER) for Medical Devices - MakroCare
Discover MakroCare's expertise in crafting comprehensive Clinical Evaluation Reports (CERs) for medical devices. Our skilled team ensures compliance with regulatory requirements and adherence to best practices, providing thorough assessments of device safety and performance data. With a focus on... -
Medical Device CRO l Clinical Vendor l Clinical Consultant – MakroCare
Makrocare Provides CRO Clinical Vendor and Clinical Consultant Services to Biopharma and Medical Device Companies. we make sure that your product complies. Explore MakroCare's cutting-edge CRO services tailored specifically for medical device clinical trials. With a focus on quality... -
Medical Device Labeling and Artwork Services - MakroCare
MakroCare provides Labeling services for Medical Device companies that span across Label creation, Label compliance, Artwork services, and review of IFU activities. Discover unrivaled expertise in medical device labeling and artwork services with MakroCare. Our comprehensive suite of solutions... -
QMS Vendor Auditor for Medical Devices | CRO Audit | MakroCare
Makrocare provides QMS Vendor Auditor & CRO Audit services to Biopharma & Medical Device Companies. Our team makes sure that your product complies. Join MakroCare's expert team as a QMS Vendor Auditor specializing in Medical Devices and CRO Audits. Contribute to ensuring top-notch quality...