The Regulatory Convergence is the premier event for regulatory professionals working in the medical device, pharmaceutical and biotech industries. It is the annual gathering of the global regulatory community bringing together the profession’s best to learn, grow, lead and share.
If you are attending the RAPS conference, be sure to visit the MedTech Review booth (#T4/T5) to meet us in person and ask any questions face-to-face. We will be showcasing our regulatory experts, Dr. Joely Gardner and Dr. Albert Rego.
Dr. Gardner is a results-oriented consultant with international expertise in usability testing, medical device testing, customer experience research, and early-stage product development. Dr. Gardner will greet participants and speak with them about the transition from a product-centered design process to a user-centered design process.
Dr. Rego is a scientific consultant to the regulated industries, with over 30 years of experience in the pharmaceutical and medical device industries. His areas of specialization are in the national and international regulatory aspects of the scientific testing requirements for chemical, biological and sterilization technologies. Dr. Rego will discuss with participants upcoming changes to the ISO 10993 biocompatibility series of standards, and the shift towards use of chemistry as a more powerful tool than biological assays.
Usability testing expert, FDA regulatory consultant
EVENT DATE: 26-27 OCTOBER
EVENT LOCATION: BALTIMORE, MD - United States of America
Analytical Chemist, Biocompatibility, FDA regulatory consultant