Regulatory, Quality Affairs Consultancy Services RQACS

Your trusted consultancy partner for Quality and Regulatory affairs.

We specialize in Medical Devices, driving Success in Medical Device Innovation with Expert Regulatory and Quality Affairs Consultancy.

At RQACS, we provide a range of expert consultancy services to help businesses like yours to achieve their goals.

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Our Services

Your one stop for multiple services!!

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ISO 9001

ISO 9001 is the internationally recognised standard for quality management within your business.

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MDR - Medical Device Regulations

ISO 45001 is the internationally recognised standard for the management of health and safety within your business. Thi-s standard has now replaced OHSAS 18001.

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MDSAP

Medical Device Single Audit Program is the process used to demonstrate your level of control over subcontracted processes.

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ISO 13485

ISO 13485 is the internationally recognised standard for quality management within the medical device sector.

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Medical Device CE Marking

Compliance with European legislation.

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Regulatory Affairs

Gain market access for cosmetics, drugs, medical devices, and natural health products (NHPs)

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Quality Affairs for Medical Devices

Ensure regulatory and quality compliance.

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Project Management

We ensure regulatory and quality compliance for products from both North American and UK/EU manufacturers

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Technical Files

Hassle-free import/export compliance management.

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About Us

At RQACS, we specialize in delivering top-notch consultancy services for international standards, regulatory compliance, and quality assurance. Our mission is to empower businesses to achieve operational excellence and market compliance.

With expertise in ISO certifications, regulatory affairs, and project management, we provide tailored solutions to meet your business needs. Trust us to guide you through complex regulatory landscapes with our proven "right-first-time" approach.

Join our growing list of satisfied clients who have achieved their goals with RQACS.

About RQACS

Book a Consultation

Schedule a meeting directly with our team at your convenience.

Contact Us

If you would like to know more about any of our services, please contact us today to arrange a no obligation free consultation to see how we can help you.