EU MDR / IVDR Consulting Services
Accelerate Your Path to CE Marking with Confidence
At MedQCompliance, we specialize in providing comprehensive EU MDR and IVDR consulting services tailored for medical device and IVD manufacturers. Navigating the complex regulatory landscape can be overwhelming — that’s why our expert team supports you end-to-end, ensuring a faster, smoother, and more predictable journey to CE approval.
Our Services Include -
Regulatory Strategy Development
Customized MDR/IVDR strategies to align with your product type, risk classification and business goals
Documentation Preparation
Expert guidance in creating and reviewing technical documentation, clinical evaluation reports, PMS/PMCF plans, and more.
Notified Body Submission Support
Full support for submissions to your chosen Notified Body, ensuring readiness and regulatory compliance
Technical Assessment Guidance
Proactive assistance during the technical file review process to address questions, resolve deficiencies, and prevent delays.
CE Audit Preparation and Support
Hands-on support before, during, and after the Notified Body audit to help you navigate assessments with confidence.
Post-Audit Assistance
Quick turnaround support to close audit findings and accelerate the final approval process.
Why Choose MedQCompliance?
- Faster Submissions: Our expertise helps you avoid common pitfalls, reducing unnecessary back-and-forth with Notified Bodies.
- Smoother Journey: We streamline the entire regulatory process, minimizing surprises during technical assessment and audits.
- Higher Approval Success Rates: With our strategic planning and thorough preparation, you increase your chances of achieving CE marking on the first attempt.
Partner with MedQCompliance
To simplify your EU MDR and IVDR compliance journey - so you can focus on innovation while we take care of your regulatory success.
Frequently Asked Questions
Get quick answers to common questions about MedQ Compliance’s services and Medtech regulatory consulting.
You can connect with us through our website, LinkedIn, Google search, or referrals to schedule an initial consultation.
MedQ Compliance specializes in preparing a tailored regulatory strategy for your medical device solution, support in building technical documentation and completing regulatory submissions in global markets such as US FDA, EU MDR/ IVDR, CDSCO India, Singapore HSA, and other countries.
MedQ Compliance prioritizes confidentiality, implementing secure processes for information protection.
Timelines for regulatory approvals depend on multiple factors such as completeness of the technical dossier, meeting applicable requirements and timely communication with the regulatory bodies. MedQ Compliance optimizes all these key areas that ensure high efficiency and minimal timelines for regulatory clearances.