Revolutionize Your Medical Device Compliance with AI.
Embrace the transformative power of our AI-driven solutions to enhance your medical device compliance processes. Our system streamlines complex audits and ensures precise NCR management, allowing you to focus on innovation and patient safety.
A Medical NCR, or Non-Conformance Report, is a quality management document used in the healthcare industry to record any instance of a product or process that does not meet the specified standards or requirements. The term "non-conformance" refers to a deviation from established protocols, standards, regulatory requirements, or product specifications.
Purpose of a Medical NCR
The main purposes of a Medical NCR include:
- Identifying Non-Conformities: Document any defects or deviations in medical products or processes.
- Root Cause Analysis: Facilitate analysis to determine the cause of the non-conformance.
- Corrective Actions: Outline the necessary steps to rectify the issue and prevent recurrence.
- Quality Improvement: Provide data to help improve the quality control process and increase patient safety.
- Compliance: Ensure that the organization remains compliant with the various regulatory bodies that govern healthcare and medical device manufacturing.
Note: This is a static demo and responses are not dynamic.
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Comprehensive Compliance Features at Your Fingertips
Streamline One is engineered for medical device professionals who demand excellence and precision. Our platform goes beyond standard compliance requirements to provide you with a suite of tools designed for the modern era of medical device regulation. Where others see limitations, Streamline One sees possibilities.
AI response:
Certainly! A PSUR, or Periodic Safety Update Report, is an important document in the field of medical devices, used to present an analysis of the risk-benefit balance of a device throughout its lifecycle. It’s a critical component of post-market surveillance under regulations such as the EU MDR (Medical Device Regulation) or the FDA’s requirements in the United States. Below is a step-by-step guide to writing a PSUR for your medical device company. Please note that this is a simplified guide, and actual regulatory requirements may be more complex and specific.
AI Regulatory Assistant
Engage with an AI-powered assistant to discuss and clarify regulatory requirements, ensuring that you have a knowledgeable resource available for addressing any compliance concerns.
Problem Summary/Identification
Describe what the problem is and how it was found...
AI NCR Report Generator
Automatically generate detailed Non-Conformance Reports (NCRs) with AI assistance, including immediate containment actions, thorough investigation, action plans, and verification steps to ensure rapid resolution and compliance.
Select a Standard to Audit Against
Upload Document for Audit | Word Document (.docx) Required
Internal Audit Compliance Tool
Utilise an advanced tool that seamlessly audits your documents and processes against selected standards, helping you to maintain compliance and prepare for internal and external audits with ease.
Elevate Your Compliance Strategy.
The landscape of medical device regulation is ever-evolving. With Streamline One, adapt quickly to regulatory changes and ensure continuous compliance. Our AI-driven platform empowers you to stay ahead, regardless of the complexity of new standards.
Comprehensive Compliance Management
Our AI-driven tools integrate seamlessly with your processes, allowing you to manage all compliance aspects with ease.
Automated Audit Trails
Effortlessly maintain complete audit trails for all your medical devices, ensuring readiness for inspections and quality checks with help from our AI Assistant.
Real-time NCR Handling
Quickly respond to and resolve non-conformance reports (NCR) with our AI-powered system that suggests corrective actions and streamlines workflows.
Collaborative Issue Resolution
Enhance team collaboration by sharing insights and resolving compliance issues with help from our AI tools.
Secure Data Protection
Protect sensitive compliance data with advanced encryption and access controls designed to meet the stringent requirements of the medical device industry.
Coming Soon | Intuitive Compliance Analytics
Gain valuable insights into your compliance status with interactive dashboards and detailed reports that help prioritize actions and improve device safety.
Transparent Pricing for Every Compliance Need.
Whether you‘re a startup navigating initial compliance hurdles or a multinational needing robust management solutions, our plans are designed to scale with your business.
Starter
£0
Perfect for newcomers to medical device compliance, offering the essentials at no cost.
- Personal AI Assistant
- AI driven NCR report writing tool
- AI driven internal audit tool
- Choose to internal audit against select standards
- All models feature our basic models
- Limited use levels each month
Professional
£49
AVAILABLE SOON | For professionals seeking comprehensive compliance management and advanced features.
- All Starter plan features
- Latest AI models available
- Access to internal audit against our full standards list
- Priority customer support
- Unlimited use
Enterprise
£199
AVAILABLE SOON | For large organizations requiring top-tier compliance solutions and full customization.
- All Professional plan features
- AI-driven compliance analytics
- Custom integration options
- Dedicated account manager
- Unlimited users and devices
Frequently asked questions
If you have anything else you want to ask, reach out to us.
How can AI improve medical device compliance?
AI can enhance compliance by automating the monitoring of regulatory changes, analyzing large sets of compliance data, and suggesting actionable insights, thereby reducing manual workload and the potential for human error.
Is my data secure with your compliance platform?
Absolutely. Our platform uses state-of-the-art encryption and robust security protocols to ensure that all your sensitive compliance data is protected in accordance with industry standards and regulations.
How do you ensure your platform stays up-to-date with regulations?
Our system is continuously updated with the latest regulatory information. Our team of compliance experts and AI algorithms work together to monitor and implement regulatory changes as they occur.
Can your platform handle global compliance requirements?
Yes, our platform is designed for global compliance management. It supports various international regulations, enabling you to manage compliance across multiple markets. You can request for new standards to be catered for in the internal audit tool.
Where is your platform hosted?
Our platform is hosted on secure cloud servers with multiple redundancy protocols to ensure high availability and data integrity, adhering to international data protection standards.
Is there any size limit to the companies that can use your platform?
Our platform is scalable and can support businesses of all sizes, from startups to large multinational corporations in the medical device industry.
How user-friendly is your compliance platform?
Our platform is designed with user experience in mind. It features an intuitive interface and guided workflows to simplify the compliance process for users at all levels of expertise.
How can I demonstrate compliance to regulators using your platform?
At the moment our platform just features tools that can make compliance more managable for smaller teams. Our platform will provide comprehensive audit trails, detailed reports, and documentation that can be presented to regulators to demonstrate compliance with medical device regulations. These features are coming soon.
How can I get started with your platform?
Getting started is simple. Just sign up on our website, and you can begin using the platform right away. We also offer resources and support to help you integrate our solution into your existing systems.