Preco, Inc. has certificates and standards focused on the medical industry to help us achieve excellence in customer satisfaction.
Director of Quality
Preco's Director of Quality, Jodi Cotten, is an FDA certified Preventive Controls Qualified Individual (PCQI). Reference
Preventive controls qualified individual means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.
Preco is highly knowledgeable and compliant with the following:
- Training and competency necessary to ensure compliance with regulatory authorities, regardless of where your device is marketed
- Staff experienced in Validation, Risk Management, 510 (k) and PMA submission support, Device History Records, and Change Management
- QMS compliant with 21 CFR 820 and MDD