Certifications & Standards

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)

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Jodi Cotten

Director of Quality
Phone:
715.247.3285

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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.
Certification

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
Contact Preco Inc

Contract Manufacturing
715.247.3285 | Email

Laser Equiment
715.247.3285 | Email

Die Cutting Equipment
913.541.0066 | Email