Medical Device Labeling Services – Overview
Medical device labeling services and Unique Device Identification (UDI) labeling requirements form a critical part of any device. They provide information to the consumer in textual or graphic forms on the packaging, with an intent to increase the safety and usage instructions for the consumers.
Medical device labeling services and UDI labeling requirements form a critical part of any device. They provide the consumer with information in textual or graphic forms on the packaging, with an intent to increase safety and usage instructions for the consumers.
Globally, misbranding and mislabeling have increased the medical device recall rate by 15%. According to the latest consensus, devices with 510k approval account for 71% of high-risk recalls. It indicates an alarming snapshot of the industry’s quality issues and a potential threat to public health. Soaring recalls lead to serious long-term reputational and financial damage. Between 2017 and 2019, 5.9% of the device recalls were attributed to mislabeling. Nearly 4,500 devices are pulled down by the United States Food and Drug Administration (US FDA) annually.
Freyr’s medical device experts are relentlessly engaged in providing end-to-end medical device labeling services throughout a device’s lifecycle. We analyze, review, track, update, and maintain UDI labeling requirements and medical device labeling requirements for device manufacturers and provide medical device labeling services and solutions right from device conceptualization to final artwork publication.
Medical Device Labeling Services
- 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 internationally 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.
