Quality Excellence Through Outsourced Expertise
We offer a comprehensive suite of quality support services to accelerate your medical device development and ensure compliance with the highest industry standards. From concept to market entry and beyond, our expertise and bespoke solutions are designed to meet your unique needs and drive success.
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Our flexible services are designed to scale with your business, ensuring you always have access to the expertise and capabilities you need.
ALIGNMENT
We work with you to identify core versus non-core activities, ensuring resources are optimised for maximum impact.
FLEXIBILITY
Our Quality Support is scalable and adaptable, tailored to meet your evolving business needs.
EXPERTISE
Access specialised skills and exclusive technologies, enhancing your competitive edge without the overhead of in-house development.
EFFICIENCY
With tools like our e-QMS Genitsys, we ensure seamless integration and real-time collaboration, enhancing quality control and operational efficiency.
Quality Management
Holistic Quality Management Support
Our Quality Management Support focuses on four essential components: Planning, Assurance, Control, and Improvement.
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We provide a holistic approach to sustain and enhance quality across your organisation. Our support is not just a one-time solution but a continuous cycle that ensures ongoing excellence within your business.
Document Control
Efficient Document Control Services
Simplify your document control process with iDE8's dedicated team. We understand the importance of every detail and work as an extension of your quality department, ensuring accurate and efficient document management for your medical device company.
Recognised internationally as subject matter experts, we excel in advanced use within global enterprise quality management systems.
Software Quality
Comprehensive Software Quality Support
With a deep understanding of diverse e-QMS environments, we tailor our services to meet your specific needs and platform. We provide comprehensive support covering implementation, optimisation, compliance, and ongoing management.
Our goal is to streamline your quality processes, ensuring they are efficient and compliant with regulatory standards, while adapting to the ever-evolving landscape of our industry.
Audit Support
Independent Quality Assurance Solutions
Our Medical Device Auditing Solutions act as your independent quality assurance, ensuring compliance and mitigating risks. We streamline the auditing process, enabling you to focus on healthcare innovation with confidence.