Goode Compliance International

Goode Compliance International (GCI) has provided expert execution of regulatory, compliance, validation, and training since 2002. That is over a decade of successful collaboration with our clients to overcome compliance obstacles by providing biomedical engineering services and solutions solely to medical device companies. Our work has a proven track record with the FDA and with our customers. We offer expert technical documentation remediation and execution in:

Design and Document Controls
Product and Process Controls including Process and Test Method Validation
Purchasing Controls and Supplier Quality
Nonconforming product and CAPA
Complaint Investigation
Risk Management

Our past and current clients can attest to the advantages of our innovative Balanced Team approach in remediating regulatory actions. If you’ve already received a 483 or Warning Letter, or are concerned your company may be in jeopardy of receiving regulatory actions, we can help. Contact us today at 954-399-7510.

Company’s Keywords:

risk management, design, process validation, regulatory compliance, capa, complaint handling, biomedical engineering