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Unlocking Precision

At Algorithmus, we specialize in providing objective analysis and evaluation of clinical data, empowering you to swiftly introduce your cutting-edge medical devices to the market. Our meticulous Clinical Evaluation process involves the comprehensive collection, assessment, and analysis of data, ensuring the safety, performance, and clinical benefits of your innovative devices.

Navigating the Ever-Changing Landscape

In an era where performance and clinical benefit requirements can evolve in an instant, our State-of-the-Art analysis ensures that your products consistently meet the exacting standards of the clinical community. By staying ahead of the curve, we equip you to confidently address the dynamic demands of the healthcare landscape.

Elevating Compliance

With the introduction of the Medical Device Regulation (MDR) in 2017, the provision of a Safety and Clinical Performance Report (SSCP) has become mandatory for manufacturers. We stand by your side, assisting you in navigating the elevated levels of regulatory compliance and fulfilling the stringent requirements imposed.

Vigilance Beyond the Market

Our vigilant Post-Market Surveillance strategies actively monitor the landscape, enabling us to detect potential complications and emerging trends at their nascent stages. By identifying early signals, we enhance the overall safety of medical devices already in circulation, fostering a culture of continuous improvement.

Precision in Post-Market Clinical Follow-up

Building upon the Clinical Evaluation results, we aid in meticulously planning your Post-Market Clinical Follow-up (PMCF) activities in accordance with MDCG 2020-7. From assisting with data collection to evaluating outcomes, we prioritize safety and performance, empowering you with valuable insights.

Mitigating Risks, Maximizing Safety

We understand that mitigating risks is paramount in ensuring the safety of medical devices. Our comprehensive risk analysis, executed in the development phase, enables early identification and minimization of potential risks through targeted measures. This proactive approach safeguards both your products and patients.

Pioneering Biocompatibility

As a manufacturer, guaranteeing the biocompatibility and biological safety (BEV) of your products is essential. Our expertise in meeting the ISO 10993 standard ensures that biological risks, such as materials causing allergic reactions, are minimized. We guide you in fulfilling these requirements to promote patient well-being.

Empowering Quality Assurance

A robust and certified Quality Management system (QMS), in accordance with ISO 13485, not only enhances control and improvement within your organization but also safeguards its long-term viability. Our commitment to establishing sustainable structures empowers you to excel in quality management.

Elevating Performance

Our holistic evaluation process encompasses clinical performance, analytical prowess, and scientific validity. By meticulously assessing these factors, we ensure that your medical devices fulfill safety requirements, deliver intended clinical benefits, and align with the the IVDR rigorous standards.