Preco, Inc. has certificates and standards focused on the medical industry to help us achieve excellence in customer satisfaction.
- ISO 13485 and ISO 9001 Certified
- (3) ISO 14644 Certified Clean Rooms
- 21 CFR 820 Compliant
- MDD 93/42/EEC Compliant
- FDA Listed (FDA Listing #’s 55-4842 & 55-4851)
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