Ensure Product Quality and Regulatory Compliance with Our Expert Support
Comprehensive Quality & Risk Management for Medical Devices
Ensuring product quality and regulatory compliance
We provide expert support for ISO 13485 QMS implementation, internal audits, supplier quality assurance, and ISO 14971 risk management.
Seamless QMS Integration
Expert Audit Support
Proactive Risk Management
How does this work?
QMS Design & Implementation
Develop and integrate ISO 13485:2016-compliant quality management systems.
Audit & Supplier Compliance
Conduct internal audits, supplier evaluations, and quality assurance checks.
Risk Management & Control
Implement ISO 14971-aligned risk assessment and mitigation strategies.
Comprehensive ISO 13485:2016 QMS Design and Implementation
Implementing a quality management system (QMS) in accordance with ISO 13485:2016 is crucial for ensuring product quality and regulatory compliance.
We offer comprehensive support for QMS design and implementation, guiding you through every step to achieve certification and enhance your quality management processes.
Standards:
- ISO 13485:2016
Services:
- Gap analysis
- QMS documentation (quality manuals, SOPs, work instructions)
- Staff training and support
Compliance Roadmap Tailored to Device-Specific Requirements
Creating a compliance roadmap tailored to your medical device’s unique requirements is crucial for regulatory success.
Our customized roadmaps outline essential steps and milestones for achieving regulatory approval.
Our approach ensures a clear, actionable path to compliance, helping you avoid delays and meet all regulatory expectations.
Services:
- Initial Gap Assessment
- Compliance Strategy Development
- Ongoing Regulatory Updates
Seamlessly Integrate QMS with Your Existing Processes
Integrating a Quality Management System (QMS) with your existing processes ensures seamless operations and regulatory compliance.
We align ISO 13485 QMS requirements with your workflows, providing tailored solutions that enhance your quality management capabilities.
Services:
- Process documentation harmonization
- Quality principles integration
- Tailored solutions for business needs
Expert Support for Internal Audit Planning and Execution
Regular internal audits are vital for maintaining an effective QMS.
We provide expert support in planning and executing internal audits to ensure ISO 13485 compliance.
Our audits help you identify areas for improvement and ensure continuous compliance with quality standards.
Services:
- Comprehensive audit plans
- Detailed audit reports
- Actionable recommendations
Maintain Supplier Quality with Comprehensive Audit Strategies
Maintaining the quality and reliability of your suppliers is crucial.
We offer comprehensive supplier audit and quality assurance strategies to manage and monitor your supply chain effectively, ensuring consistent quality across your supply chain and mitigating risks.
Services:
- Supplier audits
- Quality agreements
- Performance monitoring
Implement Effective Risk Management with ISO 14971
Implementing an effective risk management process according to ISO 14971 ensures the safety and performance of your medical devices.
We provide comprehensive risk management support to enhance your capabilities and maintain compliance.
Standards
- ISO 14971
Services
- Risk assessments
- Risk management plans
- Risk control measures
Proactive Risk Evaluation and Control Strategies
Effective risk evaluation and control strategies are critical for ensuring the safety of your medical devices.
We develop and implement risk management strategies aligned with ISO 14971, improving product safety and regulatory compliance with our proactive approach.
Standards:
- ISO 14971
Services:
- Risk assessments
- Risk control implementation
- Ongoing risk monitoring
Reach out to us and ensure Product Quality and Regulatory Compliance with Our Expert Support
Swiss MPC GmbH Riedmatt 2, 6300 Zug, Switzerland
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