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
Company Details
- Employees
- 5
- Founded
- -
- Address
- Ambachtsweg 5h, Maarsbergen,utrecht 3953 Bz,netherlands
- Industry
- Medical Device
- Website
- https://medqrconsulting.com
- Keywords
- Quality Management System, Regulatory Affairs, EU MDR, UKCA, Technical Documentation, MDSAP, FDA, ISO 13485, Internal Audit, Cybersecurity, ISO 14971, Training, Quality Assurance, Medical Devices, Risk Management, CAPA, Biological Safety Evaluation, Clinical Evaluation, ISO 10993, Post-Market Surveillance, 510k, De Novo.
- HQ
- Maarsbergen, Utrecht
Medqr Consulting Questions
Medqr Consulting's website is https://medqrconsulting.com
Medqr Consulting's LinkedIn profile is https://nl.linkedin.com/company/medqr-consulting
Medqr Consulting has
5 employees.
View email and phone details for 5
employees at Medqr Consulting.
Medqr Consulting's industry is
Medical Device
Medqr Consulting's top competitors are
Addon Ventures,
Grantly,
Tooling Studio,
Lunova,
Jongpit,
Medqair,
Vitestro,
Wildly Coaching & Advising,
Mdlaw.eu,
Create Regulatory Affairs Consultancy.
Medqr Consulting's categories are Medical Device
Medqr Consulting's founding year is 2022
