YOUR RAQA GLOBAL: Your Partner For Regulatory and Quality Compliances
Highly qualified people for regulatory compliance and quality assurance support.
YOUR RAQA GLOBAL: Your Partner For Regulatory and Quality Compliances Highly qualified people for regulatory compliance and quality assurance support.
Certify With Confidence
Empowering Medical Device Manufacturers with Global Regulatory Compliance
Your RAQA Global provides expert regulatory consulting and accredited training services tailored to medical device manufacturers, ensuring seamless compliance with international standards and certification requirements.
Strong Knowledge Strong Compliance Strong Future
Trusted Certification Experts
Your RAQA Global is a premier regulatory consultancy dedicated to empowering medical device manufacturers worldwide to achieve and maintain regulatory compliance and certification success. Our mission is to deliver expert guidance, innovative solutions, and comprehensive training programs that simplify complex regulatory landscapes. We envision a future where every medical device company confidently accesses global markets with safe, compliant products. We are driven by a culture of integrity, collaboration, innovation, and client-centric excellence, fostering long-term partnerships based on trust and measurable results.
Mission
Delivering quality certifications and consulting to elevate small businesses.
Vision
Leading India's small businesses to global standard excellence.
Values
Commitment to integrity and quality in every certification.
Quality Management System (QMS) Consulting
Regulatory Approvals & Market Access
Standards & Safety Compliance
Quality Management System (QMS) Consulting
Yourraqaglobal offers trusted ISO certifications tailored for small Indian enterprises, boosting global market readiness.
ISO 9001 Compliance Consulting
Expert support for implementing and maintaining ISO 9001 quality management systems, ensuring continual improvement and product quality consistency.
Globally Recognized
Enhances Credibility
Compliance Assurance
ISO 13485 Compliance Consultation
ISO 13485 Consulting for Medical Device Quality Management Expert ISO 13485 consulting and support from Your RAQA Global to ensure compliance and certification in medical device manufacturing.
Boost Customer Trust
Systematic Processes
International Standard
Medical Device Single Audit Program (MDSAP) Consultation
Your RAQA Global offers specialist consultation for MDSAP compliance, audit preparation, and certification integration.
Eco-Friendly Practices
Regulatory Compliance
Sustainable Growth
Gap Assessment Services
Regulatory Gap Assessment Services for Medical Device Compliance – Identify and close compliance gaps with Your RAQA Global's expert regulatory gap assessment services for medical devices.
Eco-Friendly Practices
Regulatory Compliance
Sustainable Growth
Internal and Supplier Audits
Internal and Supplier Audits for Medical Device Compliance Your RAQA Global performs thorough internal and supplier audits aligned with ISO, MDSAP, and regulatory standards for medical devices
Eco-Friendly Practices
Regulatory Compliance
Sustainable Growth
Nonconformity Resolution Support
Nonconformity Resolution Support for Medical Device Manufacturers Expert nonconformity resolution assistance from Your RAQA Global to help medical device companies address audit findings and regulatory issues.
Eco-Friendly Practices
Regulatory Compliance
Sustainable Growth
Regulatory Approvals & Market Access
Effective product compliance certifications from Yourraqaglobal help Indian SMEs align with global standards confidently.
CE Marking Guidance (MDD & EU MDR)
In-depth consultation on CE marking processes, including conformity assessment and technical documentation per the Medical Devices Directive (MDD) and Medical Device Regulation (EU MDR).
Market Access
Safety Standards
Regulatory Approval
FDA 510(k) Submission Consulting
Expert guidance on preparing and submitting 510(k) premarket notifications, demonstrating substantial equivalence for Class II devices, ensuring a streamlined pathway to U.S. market clearance.
Hazardous-free Products
Legal Compliance
Customer Safety
FDA Premarket Approval (PMA) Consulting
Comprehensive consulting for the FDA’s stringent PMA pathway, designed for high-risk Class III devices, including clinical data management, preclinical research guidance, and regulatory documentation preparation to enhance approval success.
Chemical Safety
Legal Requirements
Industry Compliance
Standards & Safety Compliance
Enhance your business quality with consulting services from Yourraqaglobal tailored for Indian SMEs.
IEC 60601 Series Compliance Consulting
Guidance on compliance with IEC 60601 electrical safety standards essential for medical electrical device market authorization.
Systematic Approach
Enhanced Efficiency
Compliance Ready
ISO 10993 Biocompatibility Standards Consultation
Professional advice on biological evaluation and testing to meet ISO 10993 biocompatibility standards.
Our Biocompatibility Partner
https://biotoxlab.in/
Skilled Auditors
Process Transparency
Continuous Improvement
State-of-the-Art (SOTA) Assessments
Advanced evaluations of device safety and technology to align with the latest regulatory expectations.
Optimized Processes
Cost Reduction
Improved Productivity
Training Programs for Regulatory and Quality Excellence
YOUR RAQA GLOBAL offers accredited, hands-on training programs aimed at empowering your team with auditing and compliance expertise
we offer customised training programs as per your needs.
Internal Auditor Training
ISO 9001 Quality Management Systems
ISO 13485 Medical Device Quality Management
MDSAP Compliance
MDD / EU MDR Regulatory Requirements
Lead Auditor Training
ISO 9001 Lead Auditor
ISO 13485 Lead Auditor
MDSAP Lead Auditor
EU MDR Lead Auditor
Post-Certification Support Services
Post-certification support services to help you maintain standards effortlessly.
Continuous Assistance
Expert Help
Smooth Transition
Why Partner with YOUR RAQA GLOBAL?
YOUR RAQA GLOBAL is the trusted partner for medical device manufacturers seeking expert regulatory guidance and premium training solutions. Our client-focused approach and global expertise help you achieve and maintain regulatory compliance confidently.
Trusted Partner
Trusted partner for comprehensive ISO certifications.
Expertise
Expertise in diverse certifications and compliance.
Continuous Support
Dedicated training and post-certification support.
Quality Focus
Focused on quality management and process improvement.
How Our Process Works
Follow these simple steps to avail our certification and consulting services hassle-free.
01.
Select Service
Choose your needed certification service to boost your business quality.
02.
Training & Support
Get expert guidance and training for smooth certification readiness.
03.
Certification
Achieve official certification with our dedicated support throughout.
Key Performance Indicators
These KPIs demonstrate Yourraqa's commitment to quality, compliance, and client development, ensuring dependable service and sustained growth.
ISO Certified
Number of successful ISO certifications delivered to trusted clients.
500+
Product Compliance
Clients achieving compliance through our product certifications.
350+
QMS Projects
Quality management projects enhancing business processes.
120+
Training Sessions
Training sessions conducted to empower client teams.
75+
What Clients Say
Discover how satisfied clients appreciate our support and expertise in certification and compliance.
Rohan
Client, Mumbai
Efficient, expert guidance on ISO and product compliance certifications.
Priya
Client, Hyderabad
Yourraqaglobal made ISO certification seamless and straightforward for us!
Arjun
Client, Delhi
Reliable consulting that helped improve our quality management systems.
Ananya
Client, Bengaluru
Their training workshops truly boosted our team's confidence and skills.
Our Professional Journey
Explore moments capturing our dedication to quality, compliance, and empowering businesses with certification expertise.
YOUR RAQA GLOBAL FAQ'S
Explore the answers to the most common queries about our certification and consulting services to empower your business growth.
Meet Our Core Team
Experienced professionals dedicated to delivering certified quality solutions.
Aarav
Founder
Driving yourraqaglobal's vision for reliable certification services.
Ananya
Quality Advisor
Enhancing business processes with expert quality improvement guidance.
Vihaan
Certification Specialist
Ensuring smooth ISO and compliance certification processes.
Isha
Training Lead
Empowering clients with impactful ISO standard trainings.
Get in Touch with Yourraqa Global
Connect with us via phone, email, or social media to learn more about our certification and consulting services.
+91 98673 93137
info@yourraqaglobal.com
A1/101 ankur recedancy, warje pune -411058
9:00 AM - 6:30 PM
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