SERVICES

Quality Services

Our human-centric approach prioritizes patient safety and user satisfaction, helping you maintain a competitive edge. Partner with us to enhance your product development process and deliver exceptional products. 

With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise in optimizing your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.  

SERVICES

Quality Services

Our human-centric approach prioritizes patient safety and user satisfaction, helping you maintain a competitive edge. Partner with us to enhance your product development process and deliver exceptional products. 

With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise in optimizing your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.  

SERVICES

Quality Services

Our human-centric approach prioritizes patient safety and user satisfaction, helping you maintain a competitive edge. Partner with us to enhance your product development process and deliver exceptional products. 

With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise in optimizing your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.  

Internal/Supplier Audits

Drive compliance and continuous improvement with our comprehensive internal and supplier audit services focusing on ISO 9001 and 13485, 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/Supplier Audits

Drive compliance and continuous improvement with our comprehensive internal and supplier audit services focusing on ISO 9001 and 13485, 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/Supplier Audits

Drive compliance and continuous improvement with our comprehensive internal and supplier audit services focusing on ISO 9001 and 13485, 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

Optimize your quality assurance processes with our tailored Quality Management System (QMS) implementation 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

Optimize your quality assurance processes with our tailored Quality Management System (QMS) implementation 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

Optimize your quality assurance processes with our tailored Quality Management System (QMS) implementation 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

Ensure your MedTech products meet stringent regulatory standards with expert guidance and support.

  • 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

Ensure your MedTech products meet stringent regulatory standards with expert guidance and support.

  • 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

Ensure your MedTech products meet stringent regulatory standards with expert guidance and support.

  • 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 

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.