Quality Management as a Service
At SBMC, we understand the critical importance of Quality Management Systems (QMS) for start-ups and small businesses aiming to navigate the stringent requirements of the Medical Device Regulation (MDR). Our Quality Management as a Service offering serves as a fundamental building block in your company’s Quality and Regulatory Strategy, providing tailored solutions to meet ISO 13485:2016 compliance standards.
Key Features:
• QMS Blueprints: SBMC offers comprehensive QMS blueprints for Quality Management processes, derived from our own robust QMS and tailored specifically for medical devices within SBMC’s scope. These blueprints serve as a roadmap for implementing essential processes such as Document and Change Control, Competence Management, Design Control, Equipment Control, and Work Environment & Infrastructure.
• Guidance and Implementation: Our experienced team provides guidance and support throughout the implementation process, ensuring seamless integration of QMS processes into your organization. We offer expert assistance in establishing and maintaining compliant QMS procedures, enabling you to focus on your core business activities.
• Partnership with Holland Innovative: SBMC has forged a longstanding partnership with Holland Innovative, offering access to additional services and expertise in establishing regulatory and quality strategies. Whether you require additional support or specialized guidance, our collaboration with Holland Innovative ensures comprehensive solutions tailored to your needs.
• Flexibility and Collaboration: We understand that every business is unique, which is why SBMC offers flexibility in our approach. We are happy to collaborate with your own consultants or preferred partners to ensure alignment with your specific requirements and objectives.
Take the first step towards establishing a robust Quality Management System for your medical devices with SBMC’s Quality Management as a Service. Contact us today to learn more about how we can support your journey towards compliance and excellence in quality management.