Case Study
Angel Medical Systems, Inc.
Business Summary Angel Medical Systems, Inc. is developing implantable cardiac monitoring systems. Angel Medical is currently in the first generation design phase of the product life cycle. Quality System Goals ? Automate quality system processes and reduce the administrative overhead of existing paper based systems. ? Utilize tools that are compliant with 21 CFR Part 820 and Part 11 out of the box (no administrative workarounds) an