Our Compliance Services
We are passionate about supporting the medtech firms to be their regulatory hand and provide them the guidance required to obtain the market approvals.
Open for Appointments
Our team is ready to assist you on your compliance journey.
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.
Quality & Regulatory 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.
Medical Device Registration Support in ASEAN Countries
Streamline market entry in ASEAN with complete regulatory support—from technical files to submission—across Singapore, Thailand, Malaysia, and the Philippines.
EU Authorized Representative Services
Ensure EU compliance with our EU Rep services—covering documentation review, regulatory communication, and incident management per MDR and IVDR standards.
EU MDR & IVDR Services
End-to-end support for CE marking: strategy, documentation, Notified Body submission, and audit readiness—guiding you through MDR and IVDR compliance with confidence.
Technical Documentation
Accelerate approvals with complete, compliant technical documentation for U.S., EU, and ASEAN markets—designed for regulatory alignment and audit readiness.
USFDA 510(k) & De Novo Submissions
Expert consulting for 510(k) and De Novo submissions—covering documentation, validation, testing, and strategy for faster FDA clearance and U.S. market access.
Compliance Services
Safeguard your products with robust risk management and streamline approvals for accelerated market entry. Elevate your MedTech journey with us.
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.
Medical Device Registration Support in ASEAN Countries
Streamline market entry in ASEAN with complete regulatory support—from technical files to submission—across Singapore, Thailand, Malaysia, and the Philippines.
EU Authorized Representative Services
Ensure EU compliance with our EU Rep services—covering documentation review, regulatory communication, and incident management per MDR and IVDR standards.
EU MDR & IVDR Services
End-to-end support for CE marking: strategy, documentation, Notified Body submission, and audit readiness—guiding you through MDR and IVDR compliance with confidence.
Technical Documentation
Accelerate approvals with complete, compliant technical documentation for U.S., EU, and ASEAN markets—designed for regulatory alignment and audit readiness.
USFDA 510(k) & De Novo Submissions
Expert consulting for 510(k) and De Novo submissions—covering documentation, validation, testing, and strategy for faster FDA clearance and U.S. market access.
Compliance and Regulatory Excellence
Why you should work with us?
MedQ Compliance brings you a suite of services designed to elevate your journey in the dynamic world of medical device compliance and regulatory excellence.
Discover how our expertise and commitment to quality can propel your innovations to new heights.
Look What Our Clients Say!!
Great Support Team
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Frequently Asked
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.