Global RQC is a consulting company that specializes in helping businesses navigate the complex world of medical device regulations and compliance.regulatory submissions They partner with manufacturers and innovators to ensure their medical devices meet strict standards set by governments and regulatory bodies around the world.
Whether it’s gaining approval to enter a new market, improving internal quality systems, or staying compliant with evolving laws, Global RQC provides expert guidance at every step.
Who Does Global RQC Serve?
Global RQC primarily serves companies that design, develop, and manufacture medical devices. These range from everyday tools like thermometers and blood pressure monitors to advanced technologies like AI-powered diagnostics and surgical robotics.
Their clients include:
- Startups entering the medical device market
- Established manufacturers expanding into global markets
- Companies needing support to comply with new or changing regulations
Global RQC is an ideal partner for businesses of all sizes that want to:
- Avoid regulatory setbacks
- Improve product quality
- Reach patients and healthcare providers around the world
What Services Does Global RQC Provide?
Global RQC offers a comprehensive range of services to ensure that medical devices are safe, compliant, and market-ready.
- Regulatory Affairs
Support in gaining product approvals from regulatory bodies such as the FDA and international authorities. Services include:
- Preparing and submitting regulatory documents (e.g., 510(k) submissions)
- Determining the right market entry pathway
- Device registration and global compliance management
- Regulatory strategy and insights
- Independent regulatory reviews
- Regulatory Compliance
Helping companies stay compliant with legal and safety standards, including:
- Addressing issues from audits or inspections
- Preparing for evaluations by regulatory agencies
- Developing corrective action plans
- Navigating complex regulations like the EU MDR
- Quality Systems
Ensuring medical devices are consistently safe and effective through strong quality systems:
- Building or improving Quality Management Systems (QMS) based on ISO 13485
- Conducting gap analyses to find process weaknesses
- Ensuring compliance with FDA and global standards
- Additional Services
Specialized support tailored to business needs:
- Market Research – Understanding new markets and opportunities
- Cost Analysis – Estimating investment for product development
- Expert Witness Testimony – Legal support in regulatory matters
- Due Diligence – Regulatory and quality evaluations for mergers or partnerships
Why Choose Global RQC?
Navigating medical device regulations is complex, time-consuming, and risky without expert help. Global RQC simplifies this process, helping companies avoid delays, rejections, and penalties.
By partnering with Global RQC, businesses can focus on innovation and quality while leaving the regulatory challenges to trusted professionals.
Looking for a partner in the medical device industry?
Global RQC is your reliable guide for regulatory compliance, quality improvement, and global market success.
