From the feasibility design stage, Kite Medtech engineers and scientists provide expert support for design control assurance on new product development teams. In addition to ensuring interpretation and application of the latest regulations, we provide strategic direction that balances risk and business goals

We interface with the R&D and core product development team to create or update Design History File (DHF), follow Engineering Change Notification (ECN) process for continued product compliance, define the right testing as per the end goal (e.g., FDA approval/clearance, CE Marking, letter to file, change notification, etc.), and ensure traceability between user needs, design inputs/outputs, verification and validation activities, and risk assessment for a robust product design documentation that serve as an evidence for a safe and effective medical device during any regulatory approval or FDA inspection process. 

We make sure the traceability of the client’s requirements by designing inputs & outputs, and verifying/validating activities. 

Some works of our expertise on Design documents are as follows. 

• User  Needs
• Design Inputs
• Design Outputs
• Design Verification
• Design Validation
• Risk Management

Our team has software, biomedical, electrical, and mechanical engineers with experience in servicing and testing. We genuinely design the product document for your device and assist you to comply with the regulatory affairs.