Partner with us to break free from conventional approaches to regulatory compliance. Let us provide the alternatives that empower your growth and innovation.

MedQR Consulting helps medical device companies succeed with high-quality Regulatory Affairs and Quality Assurance services. We ensure your products meet global standards efficiently and accurately.


We specialize in:

	•      Ensuring compliance with the European Medical
               Device Regulation (MDR) 2017/745
       •      Facilitating FDA approvals, including 510(k), De Novo, and PMA 
               submissions 
	•     Facilitating UK market access and managing UKCA
               submissions
	•     Handling global medical device registrations and
               preparing submission dossiers
	•     Developing comprehensive technical
               documentation for EU MDR compliance
	•     Conducting in-depth clinical evaluations and
               scientific reviews
	•     Executing effective Post-Market Surveillance
               strategies
	•      Expertise in biocompatibility according to ISO
               10993 series
	•	Managing cybersecurity requirements for medical
               devices
	•	Regulatory support for combination devices

Our quality assurance services include:

	•	Implementing robust quality management systems
               per ISO 13485
	•	Establishing and maintaining MDSAP-compliant
               quality management systems
	•	Conducting thorough audits in line with ISO 13485
               and MDSAP
	•	Streamlining CAPA management processes
	•	Offering expert coaching and training on ISO
               13485, MDSAP, and EU MDR standards

Connect with us for expert guidance at admin@medqrconsulting.com 

MedQR Consulting

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MedQR Consulting

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