Risk Analysis is what we do, ISO-14971 is what we know

Elevating Medical Device Innovation

Welcome to TechMed Ai, your partner in navigating the complexities of medical device development and commercialization. With a focus on risk management and regulatory compliance, we ensure your innovations not only meet industry standards but also set new benchmarks for safety and efficacy.

Our Mission

To empower medical device companies with the knowledge, tools, and strategies necessary for successful product development and market introduction. We specialize in crafting detailed risk analysis files, auditing, and enhancing them to meet and exceed regulatory requirements.

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What We Do

Risk File

• Risk Analysis File Creation: Our team of experts guides you through the creation of robust risk analysis files, ensuring comprehensive documentation and compliance with standards like ISO 14971.

• Audit and Improvement: We don’t just stop at creation. Our auditing services examine your existing risk management files for completeness, accuracy, and regulatory compliance, offering actionable insights for improvement.

• R&D and Commercialization Support: Whether you’re in the research and development phase or ready to commercialize, our consultancy provides tailored support to navigate the regulatory landscape successfully.

• Educational Resources: TechMed Ai believes in empowering our clients. We offer workshops, webinars, and a library of resources to keep you informed on the latest in medical device regulations and risk management strategies.

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Benefit-Risk Calculation

Understanding the Core of Decision-Making

In the complex journey of medical device development, navigating through design risks, implementing risk controls, and validating these controls is paramount. However, an equally critical step in this iterative process is the “Benefit-Risk Calculation (Ratio).” This stage is vital for making informed decisions on whether a medical device’s benefits to patients and users outweigh its potential risks.

The Process:

• Integration into Risk Management: Following the validation of risk controls, the Benefit-Risk Calculation is a systematic approach to evaluate the overall safety and effectiveness of the medical device. This step is crucial before circling back to the design phase, ensuring that every iteration of development enhances the device’s benefit-risk profile.
• Evaluation Criteria: The Benefit-Risk Calculation involves a thorough analysis of clinical data, user feedback, and post-market surveillance, assessing the severity and likelihood of risks against the expected clinical benefits.
• Decision-Making Framework: This phase employs a structured framework to weigh the positive impact of the device (e.g., therapeutic benefits, diagnostic accuracy) against any potential adverse effects or complications. The goal is to ensure that the device contributes a net positive effect on patient health and safety.
• Regulatory Compliance: The Benefit-Risk Calculation is not only a best practice but a regulatory requirement in many jurisdictions. It supports compliance with standards such as ISO 14971 and is a critical component of the regulatory submission process for market approval.

Expertise:

At TechMed Ai, we specialize in guiding medical device companies through the intricacies of the Benefit-Risk Calculation. Our experts provide comprehensive support, from structuring the evaluation process to interpreting the data and making the final determination on the acceptability of the benefit-risk balance. We ensure that your innovations meet the highest standards of safety, efficacy, and regulatory compliance, paving the way for successful market entry and patient impact.

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About Us
Expertise Meets Innovation

Our Story: Founded by a team of industry veterans, TechMed Ai brings together decades of experience in medical device development, regulatory affairs, and risk management consulting. Our journey began with a simple belief: that every medical device company deserves access to the highest level of expertise to bring their innovations to market safely and effectively.

Our Team: At the heart of TechMed Ai is a group of seasoned professionals, including regulatory specialists, risk management experts, and medical device engineers. Meet Ziv Kalfon, our Senior Advisor for Innovation and Strategy, whose 25-year career in MedTech innovation and leadership underscores our commitment to excellence.

Our Values: Integrity, innovation, and impact guide everything we do. We’re committed to providing services that not only meet our client’s needs but also contribute positively to the healthcare industry.

Our Clients: From startup R&D labs to established commercial phase companies, our clients are innovators looking to make a significant impact in healthcare. We’re proud to partner with them, offering tailored solutions to meet their unique challenges.

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