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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.
Post Market Clinical Follow Up (PMCF) Consulting - MakroCare
Comprehensive PMCF planning and post-market clinical follow-up (PMCF) solutions for medical devices. Your trusted PMCF partner.
Clinical Evaluation Performance (CEP) Report by MakroCare
MakroCare offers a strategy for your clinical evaluation report (CER), including clinical, safety, risk management, and literature data for clinical evaluation performance.
Clinical Evaluation Reports (CER) by MakroCare
MakroCare provides Clinical Evaluation Report (CER) services that meet the new Revision 4 requirements for European Medical Devices.
Clinical Data Management Services | MakroCare
MakroCare provides centralized clinical data management services, delivering high-quality, timely, and cost-effective solutions for Clinical Trials with customized plans.
Global Regulatory Publishing and eCTD submission Services - MakroCare
Our Submission Services are designed to facilitate advanced publishing activities and to extend the capabilities of organizations while utilizing the eCTD format.
Regulatory Affairs Consulting Services
MakroCare provides regulatory affairs consulting services and offers regulatory strategy services across product development, registration, and commercialization for medical devices.
Clinical Trial Project Management Services
MakroCare provides clinical investigation services for new device IDE studies in various therapeutic areas, including clinical study project & regulatory compliance management.
Clinical Evaluation Reports (CER) for Medical Devices
Makrocare provides Clinical Evaluation Reports (CER) compliant with Revision 4 and the European Medical Device Regulation (MDR 2017/745).
Medical Device Usability Testing Services
Makrocare provides human factors validation testing for medical devices, including formative and summative usability evaluations to support pre-market FDA submissions.
Post Market Surveillance (PMS) for Medical Devices
Makrocare offers expertise in post-market surveillance (PMS) to meet medical device market regulations and maintain compliance.
In-vitro Diagnostic Regulation (IVDR) Services
MakroCare experts guide you on how to systematically review your technical documentation and QMS ahead of GAP assessments for EU In Vitro Diagnostic Regulation (IVDR) implementation debates.
Medical Device Regulatory Updates in Global Countries
MakroCare shares information about medical device regulatory updates for Europe, Canada, the US, India, and the Philippines.
Clinical Evaluation Report (CER) Services
MakroCare provides Clinical Evaluation Report (CER) services to ensure medical device products comply with MED DEV 2.7.1 Rev 4 and Medical Device Regulations (MDR).
Biocompatibility and Biological Evaluation Reports
MakroCare's teams perform Biocompatibility advisory and Biological Evaluation Reports writing activities, including E&L projects, leveraging pre-clinical, toxicology, biomedical, and chemistry expertise.
Global Regulatory CMC consulting Services
Regulatory CMC consulting services provide regulatory strategy for authoring, preparation, publication and submission of eCTD submission applications for Pharma & life sciences.
Global Labeling for Medical Device | Labeling Artwork For Medical Device
Global labeling services for medical devices.
6 Best Practices to Navigate and Sustain Regulatory Labeling Compliance
Best practices for maintaining compliance with regulatory labeling standards and providing correct instructions for use.