Iuvo BioScience has over 30 years of expertise in designing and conducting biocompatibility programs for a range of medical device types. With regulatory and scientific expertise in global medical device development, we provide focus and efficiency to the often complex registration process. Our consultant team has been intimately involved in successfully preparing numerous medical device regulatory submissions and serving as the interface with the FDA to gain timely product registration. Our collaborative approach and deep understanding of both the science and the regulatory guidelines positions us to provide the best strategies that both accelerate timelines and reduce program risk. As your partner, you will get the full support of our expertise through-out the life cycle of your product.
Our medical device consulting services include:
- Materials qualification / Biocompatibility strategy development
- Biological evaluation reports
- Gap assessments to the ISO standards
- Study protocol design
- Safety assessments
- Study placement and monitoring
- Report preparation/review
We also serve as representatives on teams or at meetings with regulatory agencies. In addition our Quality / Regulatory consultant group can implement Design Control as part of your product development and our analytical consultants can provide expert advice on the characterization of your materials.