A new crop of medical devices currently in clinical trials is bringing personalized medicine to a new level: the devices send signals direct to the doctor’s office about operational status and any alarm thresholds, much like data center computers that can send log files and alerts to IT network administrators. Most impressive is a new heart implant that detects heart functionality, tells the patient how to adjust medication, and … Continue reading at ComplianceZen.com →
From the Blog
Lowering Liability Risks with Supplier Qualification
FDA Compliance Training – Free Consulting?
From the NIH – Biotechnology Landscape 2020
FDA Forecast for 2012
From the PCP Council Science Symposium
Client Success Stories
“Cerulean helped us understand all of the regulatory and operational considerations involved in retaining the right records. John did a great job, going above and beyond to help us see the risks we were running, draft practical policies, and suggest ways to improve while putting in a reasonable and defensible document management program of policies, procedures, and FDA records retention schedules.”
- General Counsel, Medical Device Company, Washington, D.C.
