About RQS
RQS is a consultancy specializing in guiding businesses toward achieving Quality Management Systems (QMS) certification in compliance with ISO 13485 and ISO 9001 standards. With a strategic focus on the medical sector, we navigate companies through the CE marking process for their medical devices, ensuring full compliance and market readiness.
Born from the extensive expertise of our team in Quality Management Systems, Regulatory Affairs and the medical device manufacturing industry, RQS combines innovation with experience to deliver results that matter.
Our Services
At RQS, we provide a comprehensive range of consulting services, underpinned by deep sectoral knowledge:
- Regulatory Affairs Expertise: specialized support in navigating the regulatory landscapes of medical devices, as well as expertise in adjacent sectors such as cosmetics, personal protective equipment, and veterinary products.
- Quality Management System Compliance: assistance in achieving and maintaining QMS compliance with ISO 13485 and ISO 9001, tailored to your business’s unique needs.
- Specialized Training Programs: training in Regulatory Affairs and Quality Assurance to empower teams with actionable knowledge.
- Medical Writing Services: professional drafting of medical and scientific documentation to meet the highest standards of clarity and compliance.
RQS stands ready to collaborate with your organization, combining technical rigor with a client-centric approach to deliver innovative solutions and sustainable success.
Regulatory Consulting
Quality Management Systems
Medical Writing and Documentation Editing
Regulatory Training
Expertise in MD manufacturing processes
Specialization in the biomedical sector
Flexibility of integration
Proactivity
Why choose us
At RQS, we complement our expertise in Quality Management Systems (QMS) and Regulatory Affairs by an in-depth understanding of medical device production processes. This unique combination empowers us to approach QMS and regulatory challenges with a practical, business-oriented mindset, ensuring alignment with your operational realities.
Our team comprises dynamic, dedicated professionals who collaborate closely with clients to deliver tailored solutions that meet their specific needs while maintaining full compliance with stringent medical industry standards.
Our professionalism and collaborative approach derives from a long-term experience in QMS, regulatory frameworks, and medical device manufacturing. We believe in an open, ongoing dialogue with clients to ensure solutions as effective as they are compliant.
To find out how we can assist you.