Establish tight quality systems. Respond to audits.
As a business in the medical device or life sciences industry, you live in a highly regulated world that demands stringent risk management practices and total quality management. Production and process controls are critical for sustaining your success. QUARA partners with your business to tailor total quality management systems; so you can provide the metrics and documentation that regulatory bodies demand, while gaining strategic and process advantages that will propel your business.
Manage risk and measure performance.
At QUARA, we’re problem solvers. We focus on doing more than stopping gaps that could result in regulatory action—we create risk management and design controls for a tight, compliant operation. It’s all about developing a culture of quality. We’re here to help you lay the groundwork and continually monitor and manage highly regulated internal processes.
Prepare for an audit.
Continue focusing on innovation while QUARA assures that your business is prepared for an audit, including on-site inspection management. Dealing with post-audit corrections and follow-up matters? We’ve got you covered, from inspection readiness to remediation planning.
- Risk Management
- KPI Metrics
- Design Controls
- Documentation Practices
- Management Reviews
- Computer System Validation (CSV)
- Process Improvement
- Total Quality Management
- Corrective Actions
- Remediation Planning
- ISQ 13485 Quality Systems
- Notified Body Audits
- MDD – EU Medical Device Directive
- CMDR – Canada
- Document Control
- Production and Process Controls
- Process Validation
- CAPA