ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective...
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Holistic Approach: Artixio covers the entire product life cycle, from concept inception to commercialization. Our comprehensive services ensure seamless transitions at every stage.
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Integrated Regulatory Expertise: Embedding regulatory perspective at early stage of product development is crucial for success of the medical device. Artixio’s team possesses in-depth knowledge of global regulatory requirements, ensuring compliance and timely approvals.
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Collaborative Partnership: Artixio works closely with clients, fostering a collaborative environment where ideas flourish. Our commitment to understanding client needs leads to tailored solutions.
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Quality Assurance: Rigorous quality processes are embedded in Artixio’s DNA. We prioritize safety, reliability, and effectiveness, ensuring that each device meets the highest standards.
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Innovation-Driven: Artixio thrives on innovation. Whether it’s novel designs, cutting-edge materials, or connected devices, we push boundaries to create impactful solutions.
Artixio stands out as a preferred partner for clients seeking medical device product development services. From Prototype development to Commercial Manufacturing, Artixio has partnered with seasoned teams with ISO certified facilities compliant with US FDA and EMA regulations.
Artixio's Product Development Expertise
Our Services
Our team includes Biomedical Engineers, Software Programmers, Data Engineers, Manufacturing Experts, Regulatory Professionals and Medical Devices Sales and Marketing professionals with decades of proven experience in global markets. Our team will walk with you right through the product development to commercialization journey.
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Concept Development:
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This stage involves brainstorming and defining the initial idea for a medical device. It includes identifying user needs, market research, and feasibility assessments.
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Design and Prototyping:
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Creating detailed designs, engineering specifications, and prototypes. This step ensures that the device meets safety, usability, and regulatory requirements.
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Regulatory Compliance and Quality Assurance:
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Navigating regulatory pathways (such as FDA approval) and ensuring compliance with standards. Quality assurance processes are crucial to maintain safety and effectiveness.
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Testing and Validation:
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Rigorous testing to verify the device’s performance, reliability, and safety. This includes bench testing, animal studies, and clinical trials.
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Manufacturing and Scale-Up:
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Setting up production processes, selecting suppliers, and scaling up manufacturing. Ensuring consistent quality during mass production.
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Packaging and Labeling:
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Designing packaging that protects the device and provides clear instructions. Proper labeling is essential for user safety and regulatory compliance.
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Post-Market Surveillance and Maintenance:
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Monitoring the device’s performance after commercialization. Addressing any issues, providing updates, and ensuring ongoing safety.
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User Training and Support:
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Developing training materials and providing support to healthcare professionals and end-users.
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Lifecycle Management:
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Managing changes, updates, and enhancements throughout the device’s lifecycle.
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Market Entry and Commercialization:
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Strategies for launching the device, pricing, distribution, and marketing.
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