Design controls
Transform Regulatory Requirements into Development Success.
At RA360, we make design controls work for you.
We turn complex regulatory requirements into practical processes that streamline development while ensuring compliance with ISO 13485 and 21 CFR 820.30.
A. Development of Design Control Procedures
Establishing structured design procedures creates the foundation for Efficient and compliant product development. We help you implement systems that work for your organization by:
Creating tailored procedures aligned with ISO 13485 and 21 CFR 820.30
Developing documentation templates that streamline the design process
Establishing traceability matrices connecting user needs to validation
Setting up efficient design review processes
Integrating risk management per ISO 14971 throughout development
B. Implementation of Design Control Activities
We guide your team through each phase of the design control process, turning requirements into practical development activities:
Documenting user needs and translating them into design inputs
Supporting design output development and documentation
Establishing verification and validation protocols
Conducting effective design reviews at critical stages
Creating risk analysis documentation integrated with design activities
C. Design History File (DHF) Management
A well-organized Design History File demonstrates your compliance and provides critical evidence for regulatory submissions:
Structuring DHF content for regulatory compliance
Ensuring proper documentation of design changes
Maintaining traceability throughout development
Preparing design transfer documentation for manufacturing
Supporting regulatory submissions with organized design evidence
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