D&K Engineering is committed to our clients’ success through a shared commitment to safety, innovative and cost-effective solutions, continuous improvement, and to maintaining the effectiveness of our quality and regulatory systems.

ISO Certified:

• ISO 9001:2015
• ISO 13485:2016
• FDA Registered Facility

Best Practices

• Dedicated Quality Organization
• Quality Organization Separate from Manufacturing
• Executive Management Reviews
• Quality checks integrated into the Production Process
• Internal Audits and CAPAs
• Document Control

D&K Engineering’s Quality Systems-Optimized To Manage In A High-Change Environment

D&K Engineering has a proprietary information system that links all the key elements of product design and manufacturing in a seamless system that enables complete tracking and traceability from early design through continuous manufacturing and after-market support.

Benefits of the D&K Engineering Quality System

• World Class ERP – Batch or Continuous production
• Systems validated to meet medical device control requirements
• Effective Change Management – at all stages of the PRP
• Optimized to manage change
• Fast NPI processes
• Team based access and controls provide client access and confidentiality
• Systems operate transparently across all D&K sites

Required Quality System elements are developed and tested, for each product, in the NPI phase to achieve program quality objectives and metrics