Unlocking Global Markets: regulations with us
Embark on a journey of regulatory mastery, QMS compliance and streamlined market approvals. Our tailored strategies and unwavering support redefine the path to global commercialization of your medical device solution.
Why believe in us?
Timely
approvals
Experience expedited market entry with MedQ Compliance’s streamlined processes and regulatory expertise, ensuring swift and efficient regulatory clearances for your device.
Confidentiality Assurance
MedQ Compliance is committed to ensure confidentiality of your information. Our secure processes prioritize the protection of sensitive information throughout collaborative endeavors.
Personalised Client Support
Enjoy a dedicated and tailored approach with MedQ Compliance. Benefit from clear communication, strategic guidance, and a collaborative partnership that ensures your unique needs are met.
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Discover MedQ Compliance – a beacon of excellence in MedTech regulatory support. We believe there is a significant requirement for appropriate regulatory guidance for mid and small-sized MedTech companies to build a robust regulatory strategy and obtain faster global market approvals to ensure sustainable growth. We are passionate about supporting medtech firms to be their regulatory hand and guide them to their desired regulatory goals.
Global Compliance
Ensuring your products meet global standards with precision.
8+ Years of Experience
Guiding MedTech ventures toward unparalleled success.
Complete Technical support
Guiding every aspect for your seamless Regulatory approvals
Fast Reviewals
Minimize delays, accelerate market entry with efficiency.
Compliance Services
Elevate your MedTech journey with MedQ Compliance. We offer tailored services, from ISO 13485, 21 CFR Part 820 compliance to global regulatory approvals such as USFDA, EU CE marking, CDSCO India, Singapore HSA ensuring excellence and efficiency every step of the way.
Regulatory Strategy
Craft a winning regulatory strategy with our expertise. We secure FDA, CE, and HSA approvals, keeping your products market-ready with the latest global regulatory insights.
Licensing in India
Navigate India's regulatory landscape seamlessly. We assist in ensuring CDSCO compliance and obtaining essential licenses for manufacturing and import.
Clinical Validation
Elevate your clinical validation strategy in line with regulatory requirements. Receive dedicated support for completing validation and evaluation activities, meticulously documented for regulatory compliance.
QMS Implementation
Achieve excellence in compliance with ISO 13485 and 21 CFR Part 820. Our comprehensive approach includes handholding, resource training, and obtaining ISO 13485 certification from global notified bodies.
Training Services
Empower your team with key QMS and regulatory training. Our programs foster awareness and understanding of crucial regulatory activities, enhancing overall compliance readiness.
Compliance Services
Safeguard your products with robust risk management and streamline approvals for accelerated market entry. Elevate your MedTech journey with us.
QMS Implementation
Achieve excellence in compliance with ISO 13485 and 21 CFR Part 820. Our comprehensive approach includes handholding, resource training, and obtaining ISO 13485 certification from global notified bodies.
Clinical Validation
Elevate your clinical validation strategy in line with regulatory requirements. Receive dedicated support for completing validation and evaluation activities, meticulously documented for regulatory compliance.
Training Services
Empower your team with key QMS and regulatory training. Our programs foster awareness and understanding of crucial regulatory activities, enhancing overall compliance readiness.
Regulatory Strategy
Craft a winning regulatory strategy with our expertise. We secure FDA, CE, and HSA approvals, keeping your products market-ready with the latest global regulatory insights.
Licensing in India
Navigate India's regulatory landscape seamlessly. We assist in ensuring CDSCO compliance and obtaining essential licenses for manufacturing and import.
Revolutionize Your MedTech Venture with MedQ Compliance!
Unlock regulatory mastery, ensure quality compliance, and expedite market entry. Elevate your MedTech success story with our tailored solutions and expert guidance.
Our Easy Compliance Process
Discovering MedQ Compliance
Prospective clients find us through our website, LinkedIn, Google, or referrals, forging pathways to regulatory mastery and MedTech success.
Crafting Your Regulatory Journey
After an initial strategy discussion, clients can shape their regulatory strategy and engage us for applicable projects.
Deliverables in Sync
Our collaborative approach ensures timely deliverables communicated regularly, aligned with your progress and milestones.
See What Our Clients Say’s About Us
Experience firsthand how our expertise, strategic guidance, and collaborative approach have transformed their MedTech journeys.
Regulatory Mastery
MedQ Compliance’s timely approvals were a game-changer for us. Their regulatory mastery ensured swift market entry, giving our MedTech venture the competitive edge it needed.
Technical Support
Our experience with MedQ was incredible. Their dedicated technical support and regulatory expertise propelled our venture. Seamless collaboration, timely deliverables – truly a trusted partner.
Global Assurance
MedQ Compliance’s global assurance is unmatched. Their guidance ensured our regulatory strategy aligned perfectly with international standards. A dedicated team, clear communication, and excellence in every milestone. Highly recommend.
Our Wins, In 8+ Years of experience
Frequently Asked Questions
Get quick answers to common questions about MedQ Compliance’s regulatory & quality services
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.