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Electronic IFU for Medical Devices: MDR Software - DDi

Simplify electronic IFU for medical devices with our MDR software. Ensure compliance with EU MDR regulations and streamline IFU management for efficient labeling.
https://www.ddismart.com/visu-eifu-electronic-labeling/ - Details - Similar

Regulatory, Clinical Consulting Services to Biopharma Medical Device

MakroCare is a leading clinical research organization (CRO) and regulatory affairs consulting firm providing expert services to the life sciences industry.
https://www.makrocare.com/ - Details - Similar

Regulatory Strategy for Medical Devices - FDA Consulting

MakroCare helps Medical Devices Diagnostic companies with professional FDA consulting and regulatory strategy. Trust MakroCare for an effective FDA consulting.
https://www.makrocare.com/devices/regulatory/regulatory-strategy/ - Details - Similar

Medical Device Registrations Dossiers - MakroCare

Our global Medical Device Regulatory experts are well experienced in registrations and technical files management for regulatory authorities.
https://www.makrocare.com/devices/regulatory/registrations-dossiers/ - Details - Similar

Regulatory Authorized Representative for Medical Device - FDA

MakroCare offers Regulatory Authorized Representative services FDA authorization for Medical Device in the USA and UK. We make sure your product complies.
https://www.makrocare.com/devices/regulatory/local-authorized-representative/ - Details - Similar

Medical Device QMS Consulting and SOP Management - MakroCare

MakroCare can create processes and Quality Management Systems that ensure the quality of your processes leading to fewer worries when the next audit
https://www.makrocare.com/devices/qa-qms/ - Details - Similar

Medical Devices Clinical Trial Management l PMCF CRO - MakroCare

MakroCare offers Clinical Trial Management for Medical Device and Clinical Monitoring CRO services to Biopharma and Medical Device companies.
https://www.makrocare.com/devices/clinical/trial-management/ - Details - Similar

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.
https://www.makrocare.com/devices/clinical/pmcf/ - Details - Similar

Performance Evaluation Report (PER) | IVDR PER - MakroCare

From IVDR perspective, clinical evidence should support the intended purpose of a device as stated by the manufacturer and that is based on performance evaluation. This is guided by a performance evaluation plan (PEP), a
https://www.makrocare.com/devices/clinical/performance-evaluation-report/ - Details - Similar

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.
https://www.makrocare.com/devices/clinical/cro-services/ - Details - Similar

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