Ensuring design integrity from concept to market.

Our Design Assurance services ensure that your products are developed with rigorous design controls, risk management, and validation processes to meet regulatory requirements and exceed customer expectations. Our design assurance services include:

• Design Control Implementation: Implementing robust design control processes to manage product development.

• Risk Management: Conducting comprehensive risk assessments and developing risk management plans.

• Verification and Validation: Performing thorough verification and validation activities to ensure product performance and safety.

• Design History File (DHF) Assessment: Reviewing and assessing DHFs in compliance with regulatory requirements.

Areas of Expertise:

• ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

• 21 CFR Part 820: FDA Quality System Regulation & Quality Management System Regulation (QMSR)

• 21 CFR Part 11: Electronic Records and Electronic Signatures

• IEC 60601: Medical Electrical Equipment

• IEC 62304: Medical Device Software - Software Life Cycle Processes

• ISO 14971: Medical Devices - Application of Risk Management to Medical Devices