Post-Market Regulatory Support
After a medical device has been approved and introduced to the market, it is important to ensure ongoing compliance with regulatory requirements to ensure patient safety and product effectiveness. Our team specializes in providing comprehensive post-marketing regulatory support services to medical device manufacturers.
We understand the importance of post-marketing regulatory compliance for medical device manufacturers. Our team of experts has extensive experience in navigating the complex regulatory landscape and helping manufacturers ensure ongoing compliance with regulatory requirements.
We assist manufacturers in complying with regulatory requirements for reporting adverse events related to their medical devices. Our team helps manufacturers evaluate and report adverse events to regulatory agencies in a timely manner.
Our experts provide guidance on labeling and packaging requirements, including content, format, and design. We ensure that the labeling and packaging meet regulatory requirements and are clear and accurate for healthcare professionals and patients.
We help manufacturers develop and maintain a quality system that meets regulatory requirements. Our team provides guidance on developing and implementing standard operating procedures, conducting internal audits, and addressing any compliance issues that arise.
We assist manufacturers in monitoring their medical devices after they are on the market. Our team helps develop and implement post-market surveillance plans, including data collection and analysis, to ensure ongoing product safety and effectiveness.
We conduct comprehensive assessments of manufacturers’ regulatory compliance programs. Our team identifies potential areas of risk and provides recommendations for improving compliance with regulatory requirements.