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Labeling Services
Pharma Wizard’s comprehensive medical device labeling services are designed to ensure compliance with labeling requirements. Our seasoned medical device consultants specialize in the devising of global labeling strategies, content development, and the creation, remediation, and maintenance of all labeling components.
Medical Device Labeling Services – Overview
Medical device labeling and Unique Device Identification (UDI) are essential for ensuring safety and providing clear usage instructions through text or graphics on packaging.
Pharma Wizard’s experts offer comprehensive labeling services across the entire device lifecycle — from concept to final artwork publication. We analyze, review, track, update, and maintain labeling and UDI requirements, delivering compliant and effective labeling solutions for medical device manufacturers.
Medical Device Labeling Services
- Expertise
- Global medical device labeling strategy.
- Labeling content strategy.
- Creation, remediation, and maintenance of all label components throughout the lifecycle of the device.
- Quality Management System (QMS) throughout the lifecycle of the device.
- Preparation and maintenance of reference safety information and patient guides in multiple languages.
- Gap analysis for premature labels and updating existing labels as per the country’s Regulatory demands.
- Aligning with the latest 21 CFR 801 and EU MDR Regulatory guidelines.
- Aligning with European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR) labeling compliance.
- Customizing data from primary to secondary labels.
- IFU labeling in multiple languages.
- Provision for E labeling (eIFU).
- Ensuring UDI compliance, which includes the provision of UDI labeling requirements.
- Usage of recognized symbols.
Ensuring your end-to-end labeling compliance:
- As experts, we take great care in curating the best services for our customers in MDR labeling requirements.
- Our experts cater to unique, customized, and eco-friendly labels for your medical device labeling requirements:
- Our exceptional approach and short lead times allow our customers to have the necessary workability.
- We recognize and act based on the ever-evolving global medical device labeling requirements and medical device label compliance, further reducing recalls and costs.
- We ensure the privacy, security, and audibility of your data during medical device packaging and labeling.
- We unify all the data.
At Pharma Wizard, our approach ensures dependable regulatory artwork solutions—keeping you compliant, competitive, and always on schedule.