Blaurock Consulting
Enabling Medical Device
Quality Assurance
At the Heart of Blaurock Consulting are Your Needs as a Medical Device Manufacturer
Medical devices are a tough market. We know how difficult it is to comply with ever changing regulatory requirements and still build great products with limited resources.
At Blaurock Consulting we are committed to enabling your quality team by providing rapid problem solving abilities and industry specific insights.
Gain Piece of Mind with Our Services
Efficiency
We are always striving to improve the status quo. Greater compliance with less effort.
Execution
Full hands-on execution of design controls, process validations, CAPAs, NCs, risk management, requirements engineering and software validation.
Training
At the heart of our trainings is the WHY. Enabling your team to see the why and enabling them to steer in the right direction. Getting the rights things done.
Testimonials
Recent Projects Completed
CAPA Remediation
- Execution of the CAPA process
- Root Cause Analysis
- Creation of CAPA action plans
- Tracking and execution of CAPA actions
- Processing of Verification of Effectiveness
Quality Engineering New Device
- Approval of Verification Plans and Reports for new device
- Design Change Management
- Software Anomaly Management
- Approval of Risk Management Files
- Support of 510(k) submission
Software Validation
- User Requirements creation
- Test Protocol creation
- SW Test execution
- Test Report creation