Empowering Tomorrow's Health Innovations Today

At knoell, we understand the critical importance of your Quality Management System (QMS), and we are dedicated to supporting and enhancing your QMS to ensure the success of your medical device regulatory approval processes. Our focus is on collaboratively creating and maintaining robust QMS tailored to your specific needs.

With a team of devoted scientific experts, we view your QMS not merely as a set of rules but as the cornerstone of your confidence in us. By entrusting us with your QMS, you can be confident that we will not only meet but exceed industry expectations, providing you with a solid foundation for the reliability, safety, and success of your products.

• Support in implementing Quality Management Systems in accordance with ISO 9001:2015, ISO 13485:2016 and ISO/IEC 27001:2022 

  With the support of our external partners, we specialize in providing comprehensive support for the implementation of Quality Management Systems (QMS) aligned with ISO 9001:2015, ISO 13485:2016, and ISO/IEC 27001:2022 standards. Our dedicated team of experts ensures transparency in guiding organizations through the process of establishing robust QMS frameworks tailored to meet the specific requirements of each ISO standard with the support of our partners! Whether it's quality management for general business processes (ISO 9001), medical device manufacturing (ISO 13485), or information security (ISO/IEC 27001), we offer hands-on assistance in documentation, process optimization, and compliance. Our goal is to empower organizations to achieve and maintain certification, enhancing operational efficiency, product quality, and information security.

• Performing internal audits for Quality Management Systems in accordance with ISO 9001:2015, ISO 13485:2016 and ISO/IEC 27001:2022

  We excel in conducting internal audits for Quality Management Systems (QMS) in strict adherence to ISO 9001:2015, ISO 13485:2016, and ISO/IEC 27001:2022 standards. Our experienced team is dedicated and proficient in systematically evaluating organizational processes, ensuring they align with the specified ISO requirements locally and globally. Through our meticulous internal audits, we identify areas for improvement, assess compliance, and provide valuable insights for enhancing the effectiveness of QMS implementation. Whether it's quality management for general business operations, medical device manufacturing, or information security, our internal audit services are designed to support organizations in maintaining and enhancing their adherence to ISO standards, fostering continual improvement and sustained excellence.

• Supporting the development, implementation, distribution and maintenance of medical device software /software as a medical device (SaMD) in accordance with Medical Device Regulation 2017/745 and standards as e.g. IEC 62304:2015, IEC 82304:2016 etc.

  We specialize in providing comprehensive support for the entire lifecycle of medical device software and Software as a Medical Device (SaMD), in strict accordance with the Medical Device Regulation 2017/745 and relevant standards such as IEC 62304:2015, IEC 82304:2016, and others. Our dedicated team is experienced in guiding the development, implementation, distribution, and ongoing maintenance of software solutions, ensuring compliance with regulatory requirements. Whether you are navigating the complexities of software development or seeking adherence to specific standards, we offer tailored assistance to foster the successful deployment and maintenance of medical device software, facilitating regulatory compliance and optimal performance throughout the product lifecycle.
  

Are you seeking assistance in registering your medical devices to meet biological safety standards? The knoell team, comprised of global experts, possesses comprehensive experience across various medical device categories. Gain access to our in-house specialists in analytical chemistry, toxicology, endocrine disruptors, CMRs, QSAR, nanomaterials, and more. Explore our diverse range of services and get in touch with us!

• Compilation of Biological Evaluation Plan

  Regulatory compliance requires a robust, methodical biological evaluation plan, in accordance with the relevant regulatory guidelines and standards, and the applicable regional medical device regulations. We tailor your individual biological evaluation plan to be compliant with ISO 10993 (as well as ISO 18562 or ISO 7405, as required), and to meet the expectations of regional regulatory bodies (e.g. EU-notified bodies, MHRA or US FDA), specific to your medical device and your marketing plans. The biological evaluation plan includes a material characterization and data gap analysis, biological evaluation strategy development, and recommendations for chemical/analytical and toxicological/biological testing.

• Study concept management and study monitoring

  Conducting an analytical (extractable and leachable (E/L)) or biocompatibility study requires adherence to current standards to reliably fulfill regulatory requirements. As study monitors, we assist you in conducting your study from the request for quotation at contract research organizations (CROs) to the final study report; thus ensuring that your study will be performed according to the highest standards and as specifically as required for your medical device. We liaise directly with the laboratory to provide support throughout the full study period, and to ensure timely input from our toxicologists whenever required.

• Toxicological risk assessment of extractable/leachable substances

  The toxicological risk assessment and establishment of allowable limits for raw materials, or E/Ls detected during chemical characterization is performed following the process described in ISO 10993-17. Based on existing toxicological data on the substances, and taking the medical device's specific exposure conditions into account, we characterize the toxicological risk associated with the medical device's use.

• Alternative Assessment Approaches

  Alternative assessment approaches, e.g., in silico modeling (Quantitative Structure-Activity Relationship QSAR), grouping, or read-across are used. The toxicological risk assessment of E/Ls is regarded in the context of the overall biological response to the final product, providing a powerful tool to avoid unnecessary animal testing.

• Compilation of a Biological Evaluation Report

  Biological evaluation report summarizes all data and findings gathered during the biological evaluation. Integrating all relevant information, from material and chemical characterization to toxicological risk assessment, it provides an overall conclusion on the biological safety of your device.

• Zoonosis Risk Assessment for Materials of Animal Origin

  For medical devices utilizing materials of animal origin, a zoonosis risk assessment in accordance with the ISO 22442 series is required within the risk management process. The risk of zoonotic pathogen transmission to humans and subsequent infection due to the medical device use is evaluated. Information on starting material, pathogen burden, production process, and susceptibility of pathogens to inactivation through the production process is compiled and assessed. In cases of a non-acceptable residual risk, further investigation is triggered, and risk mitigation measures proposed.

• Training

  Do you need help for your teams to gain more insights into biocompatibility and biological evaluation processes of your medical devices? We provide in-house training tailored to your specific requirements and concerns.

Our consulting services extend to the development, implementation, distribution, and maintenance of digital solutions used in medical contexts and health environments. While these solutions may not be classified as medical devices, they play a crucial role in healthcare settings. Our experienced team offers guidance tailored to the unique challenges of the healthcare industry, ensuring compliance with relevant standards and regulations. Whether it's optimizing workflows, enhancing data security, or streamlining digital processes, our consulting services are designed to support the effective utilization of digital solutions within the dynamic landscape of healthcare.

At knoell, we simplify the medical device registration process with support of our partners by offering practical assistance:

• Guidance: Our experienced team provides clear guidance on the registration process, ensuring you understand requirements and timelines.
  
  
• Documentation Assistance: We help organize and prepare essential documentation for regulatory submissions, making the application process smoother.
  
  
• Regulatory Compliance: Our experts ensure your medical devices comply with regulatory standards, reducing the risk of delays or rejections.
  
  
• Government Notification: We manage the regulatory notification process to government authorities, ensuring accurate and timely submissions.
  
  
• Updates: Stay informed with regular progress updates, providing transparency and confidence throughout the regulatory journey.