We collaborate with the R&D and core product development teams to build or remediate Design History File (dhf) to adhere to the Engineering Change Notification (ecn) protocol. We specify the appropriate testing in accordance with the end goal and to ensure a continued product compliance.
- User needs identification and definition
- Instructions For Use
- System requirement specifications
- Labelling documents
- Software requirement specifications (SRS)
- Label review for compliance
- Software Design Specifications (SDS)
- Performance testing
- Traceability matrix
- Bench testing
- Architecture design chart
- Third-party – IEC 60601, ISO 10993, ISO 11607
- Software Level of Concern
- New Product Development (NPD) Quality Engineering
- Software Development Environment Description (SDED)
- Device History Record (DHR) & Device Master Record (DMR) creation and updates
- Risk assessment (ISO 14971)
- Shipping labels
- Risk management updates
- Supplier identification
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Regulatory Compliance
We pride ourselves on being experts in quality assurance , we are passionate about helping you meet high quality and sustainable Quality Management Systems.
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Quality Assurance
Our experts combine their experience and know-how to build and update your device's design history in line with the quality systems and regulatory requirements.
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