Medical Device Design Control Services

Design control compliance services are intended to help companies comply with the design control requirements of the FDA (CFR 820.30), ISO 9001:1994/ISO13485, and ISO 9001:2000. The following are services we provide:

• Design Control System and Procedure Development
• Quality Planning for Development Project
• Design Documentation Compliant with Design Control

» Specification development
» Design descriptions
» Specification update
» Design Reviews

• Design Validation and Verification, including Software
• Risk Analysis, FMEA Analysis, FTA Analysis
• Requirements Traceability and Configuration Management
• Process Validation
• Training
• Documentation Development for Existing Medical Devices
• Assistance in device classification

» Determination of Class I, Class II, Class III, or Combination thereof

• Design Control System and Procedure Development

 

Design Control Relation to FDA Submissions:

• Medical devices are subject to various regulations in terms of submission and approval (FDA)
• Design control deliverables are needed for the submission packages in many cases

Related links:

FDA's Design Control Guidance: http://www.fda.gov/cdrh/comp/designgd.html

Global Harmonization Task Force: http://www.ghtf.org/