QUALITY & COMPLIANCE
We accelerate the development of digital strategies, medical products, and solutions in life sciences companies by integrating health authorities' requirements into your business, quality, and compliance models.
The mission of modern healthcare is to provide patients today with the products and solutions of the future. With our Quality, Compliance and Regulatory Affairs services, we establish a stable foundation for a fast and compliant product development and market approval.
QUALITY & COMPLIANCE
We accelerate the development of digital strategies, medical products, and solutions in life sciences companies by integrating health authorities' requirements into your business, quality, and compliance models.
The mission of modern healthcare is to provide patients today with the products and solutions of the future. With our Quality, Compliance and Regulatory Affairs services, we establish a stable foundation for a fast and compliant product development and market approval.
Our team of certified experts, with extensive industry experience, will manage your projects and initiatives with thought leadership, dedication, and passion.
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OUR SERVICES
DIGITAL HEALTH & EMERGING TECHNOLOGIES
We integrate modern technologies into the healthcare sector. In doing so, we accompany you from identifying meaningful use case ideas and regulatory assessments to the approval of mobile apps or the implementation of your digital solution.
QUALITY, REGULATORY & COMPLIANCE EXCELLENCE
We accelerate your business models through regulatory compliant processes. With our regulatory understanding of the requirements of the authorities, we advise you in quality, regulatory and compliance and create intelligent processes and frameworks.
LEADING EDGE VALIDATON
We validate digital solutions in an audit-proof and cost-efficient manner. With our best practices, you meet the highly regulated requirements of the FDA and EU. From validation strategy to change and release management, we ensure a future-oriented focus.
SOFTWARE AS A MEDICAL DEVICE
We advise you on the compliant development of medical devices as standalone software or embedded software. Our experts accompany you from the idea and conception through validation and approval to sustainable anchoring in your organization.
ORGANIZATIONAL & PERSONAL DEVELOPMENT
We empower people and organizations. Through mentoring and training in a regulated environment, we promote reflective thinking and action. Thus, we create the basis for the agile and future-oriented development of your organization.
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OUR SERVICES
We provide a holistic approach from analysis to implementation and ensuring successful anchoring into your operational business:
DIGITAL HEALTH & EMERGING TECHNOLOGIES
We integrate modern technologies into the healthcare sector. In doing so, we accompany you from identifying meaningful use case ideas and regulatory assessments to the approval of mobile apps or the implementation of your digital solution.
QUALITY, REGULATORY & COMPLIANCE EXCELLENCE
We accelerate your business models through regulatory compliant processes. With our regulatory understanding of the requirements of the authorities, we advise you in quality, regulatory and compliance and create intelligent processes and frameworks.
LEADING EDGE VALIDATON
We validate digital solutions in an audit-proof and cost-efficient manner. With our best practices, you meet the highly regulated requirements of the FDA and EU. From validation strategy to change and release management, we ensure a future-oriented focus.
SOFTWARE AS A MEDICAL DEVICE
We advise you on the compliant development of medical devices as standalone software or embedded software. Our experts accompany you from the idea and conception through validation and approval to sustainable anchoring in your organization.
ORGANIZATIONAL & PERSONAL DEVELOPMENT
We empower people and organizations. Through mentoring and training in a regulated environment, we promote reflective thinking and action. Thus, we create the basis for the agile and future-oriented development of your organization.
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OUR PROJECT REFERENCES
Software as a Medical Device (Digital Health)
Validation of Digitalized Regulatory Affairs Processes
Transfer of Design Projects into Serial Production
We enable the transition of medical device development projects from design to serial production, while ensuring adherence to quality and compliance standards. This includes creating process documentation, qualifying equipment, and integrating stakeholder input with process requirements. We manage, control and optimize the projects to enhance both production processes and related validation activities.
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OUR PROJECT REFERENCES
Software as a Medical Device (Digital Health)
Validation of Digitalized Regulatory Affairs Processes
Transfer of Design Projects into Serial Production
We enable the transition of medical device development projects from design to serial production, while ensuring adherence to quality and compliance standards. This includes creating process documentation, qualifying equipment, and integrating stakeholder input with process requirements. We manage, control and optimize the projects to enhance both production processes and related validation activities.
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YOUR CONTACT
Do you have a specific Quality & Compliance question?
Talk to us! If we can process your request with little effort, we will provide you with a complimentary consultation. For a more complex analysis or additional information, we will be happy to contact you personally for further clarification.
Contact our driving mentor Sandra Weniger-Niederberger at:
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YOUR CONTACT
Would you like to learn more about Quality & Compliance?
Talk to us! If we can process your request with little effort, we will provide you with a complimentary consultation. For a more complex analysis or additional information, we will be happy to contact you personally for further clarification.
Contact our driving mentor Sandra Weniger-Niederberger at: