Our Regulatory Affairs service ensures your medical devices and IVDs meet all required compliance standards for safe and successful market entry. We guide manufacturers through the complex regulatory landscape and provide complete support across MDR, IVDR, UKCA, and Swiss regulations.
Built for Compliance, Speed, and Market Success
We deliver structured, reliable, and audit-ready regulatory solutions designed to accelerate approvals and ensure long-term compliance.
- Comprehensive MDR/IVDR Expertise
- Clear Regulatory Roadmaps
- Audit-Ready Documentation
- Faster Market Access
- Global Regulatory Support
- Ongoing Compliance Monitoring
What We Offer ?
Clear, customized regulatory roadmaps aligned with your device type, risk class, and intended markets.
Direct support in managing feedback, clarifications, and regulatory interactions to avoid delays.
Continuous monitoring, updates, renewals, and support to maintain long-term regulatory compliance.
Preparation and review of MDR/IVDR documentation, ensuring full compliance and readiness for Notified Body and Competent Authority evaluation.
Why Choose Qualitech International ?
Proven Regulatory Expertise
Our team brings extensive experience with MDR, IVDR, UKCA, and Swissmedic requirements, ensuring accurate and compliant outcomes.
High-Quality, Audit-Ready Outputs
Every document is structured, validated, and delivered to meet Notified Body and Competent Authority expectations.
Faster & Smoother Approvals
We optimize regulatory pathways, anticipate obstacles, and support you through every step to reduce time-to-market.
Frequently Asked Questions
Have questions about regulatory compliance, market access, or our services?
Here are answers to the most common inquiries from Medical Device and IVD manufacturers.
How long does the EU MDR/IVDR transition process typically take?
The timeline varies heavily depending on the device classification and current state of your QMS. A full transition can take anywhere from 6 to 18 months. We conduct an initial gap analysis to provide a precise timeline.
Can you help us communicate with our Notified Body?
Absolutely. We act as your strategic representatives, handling complex communications and defending your technical files during Notified Body audits.
Do you support Post-Market Surveillance (PMS) after certification?
Yes. We offer continuous retainer services that include PSURs, PMCF planning, and maintaining your QMS post-certification to guarantee ongoing compliance.
