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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

Clinical Operations Monitoring - MakroCare

Clinical operations monitoring services for Medical device in the USA and Europe provided by MakroCare. CRAs with experience assuring regulatory compliance.
https://www.makrocare.com/devices/clinical/clinical-operations-monitoring/ - 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

Clinical Evaluation Report (CER) for Medical Devices - MakroCare

MakroCare help you ensure that your Clinical Evaluation Report (CER) meet strict new requirements of Rev 4 and the European Medical Device Regulation (MDR 2017/745) and MakroCare will assist you in completion of your CER
https://www.makrocare.com/devices/clinical/clinical-evaluation-reports/ - 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

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.
https://www.makrocare.com/devices/audits/ - Details - Similar

Clinical Data Management Outsourcing l Statistical CRO l Medical Devic

Outsource your medical device clinical data management to MakroCare, a statistical CRO providing data management services for medical devices.
https://www.makrocare.com/devices/clinical/clinical-data-management-statistics/ - 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

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 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

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