SERVICES
Quality Services
At ClariMed, we embed quality principles throughout the product development lifecycle. Our comprehensive approach integrates user-focused quality systems early, optimizing processes and prioritizing patient safety at every decision point. Through our proven methodologies, we empower clients to bring safer, more effective medical devices to market while maintaining regulatory compliance and competitive advantage.
SERVICES
Quality Services
At ClariMed, we embed quality principles throughout the product development lifecycle. Our comprehensive approach integrates user-focused quality systems early, optimizing processes and prioritizing patient safety at every decision point. Through our proven methodologies, we empower clients to bring safer, more effective medical devices to market while maintaining regulatory compliance and competitive advantage.
SERVICES
Quality Services
At ClariMed, we embed quality principles throughout the product development lifecycle. Our comprehensive approach integrates user-focused quality systems early, optimizing processes and prioritizing patient safety at every decision point. Through our proven methodologies, we empower clients to bring safer, more effective medical devices to market while maintaining regulatory compliance and competitive advantage.
Internal and Supplier Audits
Drive compliance and continuous improvement with our comprehensive internal and supplier audit services focusing on ISO 9001 and 13485, EU MDR, CMDR, and MDSAP.
Conduct thorough audits of internal processes and supplier quality systems
Identify areas of non-compliance and opportunities for improvement
Develop and implement effective corrective and preventive actions (CAPAs)
Monitor and report on audit findings and CAPAs to ensure continuous improvement
Internal and Supplier Audits
Drive compliance and continuous improvement with our comprehensive internal and supplier audit services focusing on ISO 9001 and 13485, EU MDR, CMDR, and MDSAP.
Conduct thorough audits of internal processes and supplier quality systems
Identify areas of non-compliance and opportunities for improvement
Develop and implement effective corrective and preventive actions (CAPAs)
Monitor and report on audit findings and CAPAs to ensure continuous improvement
Internal and Supplier Audits
Drive compliance and continuous improvement with our comprehensive internal and supplier audit services focusing on ISO 9001 and 13485, EU MDR, CMDR, and MDSAP.
Conduct thorough audits of internal processes and supplier quality systems
Identify areas of non-compliance and opportunities for improvement
Develop and implement effective corrective and preventive actions (CAPAs)
Monitor and report on audit findings and CAPAs to ensure continuous improvement
QMS Implementation, Maintenance and Remediation
Establish, optimize or maintain your quality assurance processes with our tailored QMS services. Let our team support your internal quality operations with everything from CAPA and complaints to suppliers, management reviews, and material inspection.
Design and document QMS processes and procedures tailored to your organization
Train your staff on QMS requirements and procedures to ensure smooth adoption
Implement QMS processes and tools to streamline your quality assurance efforts
Monitor and measure QMS performance to identify areas for optimization
Conduct regular QMS audits and management reviews to maintain compliance
QMS Implementation, Maintenance and Remediation
Establish, optimize or maintain your quality assurance processes with our tailored QMS services. Let our team support your internal quality operations with everything from CAPA and complaints to suppliers, management reviews, and material inspection.
Design and document QMS processes and procedures tailored to your organization
Train your staff on QMS requirements and procedures to ensure smooth adoption
Implement QMS processes and tools to streamline your quality assurance efforts
Monitor and measure QMS performance to identify areas for optimization
Conduct regular QMS audits and management reviews to maintain compliance
QMS Implementation, Maintenance and Remediation
Establish, optimize or maintain your quality assurance processes with our tailored QMS services. Let our team support your internal quality operations with everything from CAPA and complaints to suppliers, management reviews, and material inspection.
Design and document QMS processes and procedures tailored to your organization
Train your staff on QMS requirements and procedures to ensure smooth adoption
Implement QMS processes and tools to streamline your quality assurance efforts
Monitor and measure QMS performance to identify areas for optimization
Conduct regular QMS audits and management reviews to maintain compliance
Document Management
Ensure accuracy, accessibility and compliance with our robust document management solutions.
Design and implement a compliant and effective document management system
Establish document control procedures and templates to ensure consistency
Train your staff on document management requirements and procedures
Conduct regular document audits and reviews to maintain accuracy and accessibility
Document Management
Ensure accuracy, accessibility and compliance with our robust document management solutions.
Design and implement a compliant and effective document management system
Establish document control procedures and templates to ensure consistency
Train your staff on document management requirements and procedures
Conduct regular document audits and reviews to maintain accuracy and accessibility
Document Management
Ensure accuracy, accessibility and compliance with our robust document management solutions.
Design and implement a compliant and effective document management system
Establish document control procedures and templates to ensure consistency
Train your staff on document management requirements and procedures
Conduct regular document audits and reviews to maintain accuracy and accessibility
Regulatory Compliance
Leverage our expert guidance to ensure your products meets the stringent regulatory standards required for medical devices, combination products, or IVD devices. Facilitate faster product approval and market entry!
Identify applicable regulations and standards for your MedTech products
Assess your current compliance status and perform gap analyses
Develop and implement compliance strategies and action plans
Monitor and report on compliance performance to avoid regulatory enforcement actions
Communicate with regulatory agencies as needed to maintain positive relationships
Regulatory Compliance
Leverage our expert guidance to ensure your products meets the stringent regulatory standards required for medical devices, combination products, or IVD devices. Facilitate faster product approval and market entry!
Identify applicable regulations and standards for your MedTech products
Assess your current compliance status and perform gap analyses
Develop and implement compliance strategies and action plans
Monitor and report on compliance performance to avoid regulatory enforcement actions
Communicate with regulatory agencies as needed to maintain positive relationships
Regulatory Compliance
Leverage our expert guidance to ensure your products meets the stringent regulatory standards required for medical devices, combination products, or IVD devices. Facilitate faster product approval and market entry!
Identify applicable regulations and standards for your MedTech products
Assess your current compliance status and perform gap analyses
Develop and implement compliance strategies and action plans
Monitor and report on compliance performance to avoid regulatory enforcement actions
Communicate with regulatory agencies as needed to maintain positive relationships
Training and Education
We offer tailored training programs on QMS, regulatory standards, and best practices. Let us build-in house experience for your team!
Provide tailored training programs on QMS
Offer guidance on regulatory standards
Share industry best practices
Build in-house expertise for your team
Training and Education
We offer tailored training programs on QMS, regulatory standards, and best practices. Let us build-in house experience for your team!
Provide tailored training programs on QMS
Offer guidance on regulatory standards
Share industry best practices
Build in-house expertise for your team
Training and Education
We offer tailored training programs on QMS, regulatory standards, and best practices. Let us build-in house experience for your team!
Provide tailored training programs on QMS
Offer guidance on regulatory standards
Share industry best practices
Build in-house expertise for your team
CAPA
Identifying root causes of non-conformities and implementing effective corrective actions. This will enhance product and process reliability.
Identify root causes of non-conformities
Implement effective corrective actions
Enhance product and process reliability
Monitor ongoing effectiveness
CAPA
Identifying root causes of non-conformities and implementing effective corrective actions. This will enhance product and process reliability.
Identify root causes of non-conformities
Implement effective corrective actions
Enhance product and process reliability
Monitor ongoing effectiveness
CAPA
Identifying root causes of non-conformities and implementing effective corrective actions. This will enhance product and process reliability.
Identify root causes of non-conformities
Implement effective corrective actions
Enhance product and process reliability
Monitor ongoing effectiveness
Risk Management
Reduce product-related hazards and enhance patient safety. Implement risk management processes in line with ISO 14971 to identify, analyze, and mitigate risk.
Implement ISO 14971-aligned processes
Identify, analyze, and mitigate risks
Reduce product-related hazards
Enhance patient safety
Risk Management
Reduce product-related hazards and enhance patient safety. Implement risk management processes in line with ISO 14971 to identify, analyze, and mitigate risk.
Implement ISO 14971-aligned processes
Identify, analyze, and mitigate risks
Reduce product-related hazards
Enhance patient safety
Risk Management
Reduce product-related hazards and enhance patient safety. Implement risk management processes in line with ISO 14971 to identify, analyze, and mitigate risk.
Implement ISO 14971-aligned processes
Identify, analyze, and mitigate risks
Reduce product-related hazards
Enhance patient safety
Usability Engineering Documentation
Allow our experts to craft your IEC-62366-1 aligned usability engineering documentation that will support your human factors studies and usability testing. The goal should always be to ensure devices are safe, effective, and user-friendly!
Create IEC-62366-1 aligned documentation
Support human factors studies
Enable effective usability testing
Ensure devices are safe and user-friendly
Usability Engineering Documentation
Allow our experts to craft your IEC-62366-1 aligned usability engineering documentation that will support your human factors studies and usability testing. The goal should always be to ensure devices are safe, effective, and user-friendly!
Create IEC-62366-1 aligned documentation
Support human factors studies
Enable effective usability testing
Ensure devices are safe and user-friendly
Usability Engineering Documentation
Allow our experts to craft your IEC-62366-1 aligned usability engineering documentation that will support your human factors studies and usability testing. The goal should always be to ensure devices are safe, effective, and user-friendly!
Create IEC-62366-1 aligned documentation
Support human factors studies
Enable effective usability testing
Ensure devices are safe and user-friendly
Supplier Quality Management
Ensure quality of components, materials, or services outsourced by implementing robust supplier performance and compliance criteria.
Implement supplier performance criteria
Establish compliance requirements
Monitor supplier quality
Manage outsourced components and services
Supplier Quality Management
Ensure quality of components, materials, or services outsourced by implementing robust supplier performance and compliance criteria.
Implement supplier performance criteria
Establish compliance requirements
Monitor supplier quality
Manage outsourced components and services
Supplier Quality Management
Ensure quality of components, materials, or services outsourced by implementing robust supplier performance and compliance criteria.
Implement supplier performance criteria
Establish compliance requirements
Monitor supplier quality
Manage outsourced components and services
Design Controls
Allow our experts to create your processes for design and development in compliance with regulatory requirements and user needs.
Create processes for design and development
Ensure compliance with regulatory requirements
Address user needs throughout development
Document design history and changes
Design Controls
Allow our experts to create your processes for design and development in compliance with regulatory requirements and user needs.
Create processes for design and development
Ensure compliance with regulatory requirements
Address user needs throughout development
Document design history and changes
Design Controls
Allow our experts to create your processes for design and development in compliance with regulatory requirements and user needs.
Create processes for design and development
Ensure compliance with regulatory requirements
Address user needs throughout development
Document design history and changes
Software Validation
Ensure reliability and compliance of your software systems in line with IEC 62304 or FDA guidelines.
Ensure reliability of software systems
Maintain compliance with IEC 62304
Follow FDA guidelines
Validate software functionality
Software Validation
Ensure reliability and compliance of your software systems in line with IEC 62304 or FDA guidelines.
Ensure reliability of software systems
Maintain compliance with IEC 62304
Follow FDA guidelines
Validate software functionality
Software Validation
Ensure reliability and compliance of your software systems in line with IEC 62304 or FDA guidelines.
Ensure reliability of software systems
Maintain compliance with IEC 62304
Follow FDA guidelines
Validate software functionality
Post Market Surveillance
Allow our team to support your PMS activities, including complaint handling and reporting adverse events.
Support PMS activities
Handle complaints effectively
Report adverse events
Monitor product performance
Post Market Surveillance
Allow our team to support your PMS activities, including complaint handling and reporting adverse events.
Support PMS activities
Handle complaints effectively
Report adverse events
Monitor product performance
Post Market Surveillance
Allow our team to support your PMS activities, including complaint handling and reporting adverse events.
Support PMS activities
Handle complaints effectively
Report adverse events
Monitor product performance
Process Validation and Verification
Ensure consistent production of compliant products by allowing our experts to guide process validation, test method validation, and equipment qualification.
Guide process validation procedures
Conduct test method validation
Perform equipment qualification
Ensure consistent production quality
Process Validation and Verification
Ensure consistent production of compliant products by allowing our experts to guide process validation, test method validation, and equipment qualification.
Guide process validation procedures
Conduct test method validation
Perform equipment qualification
Ensure consistent production quality
Process Validation and Verification
Ensure consistent production of compliant products by allowing our experts to guide process validation, test method validation, and equipment qualification.
Guide process validation procedures
Conduct test method validation
Perform equipment qualification
Ensure consistent production quality
Let's work together!
Contact us to discuss how we can advance your medical device development efforts together.
Let's work together!
Contact us to discuss how we can advance your medical device development efforts together.
Let's work together!
Contact us to discuss how we can advance your medical device development efforts together.