Global Expertise

Empowering Tomorrow's Health Innovations Today

Elevate Your Medical Devices with knoell's Expertise and Excellence!

Navigating Medical Device Development and Compliance Excellence

Welcome to knoell Medical Devices, your premier partner in navigating the intricate landscape of medical device development and market entry. Specializing in a wide array of products, from wound dressings to long-term implants, we offer comprehensive support to ensure your devices meet and exceed regulatory standards. With our team of experts boasting deep knowledge and extensive experience, knoell Medical Devices is committed to guiding you through the complexities of compliance and quality assurance, making your journey to market both smooth and successful. Join us in elevating healthcare innovation with precision and proficiency.

Our Services

How can we help you?

knoell Medical Devices specializes in providing invaluable assistance in regulatory affairs with the support of reliable partners. Combined we offer comprehensive solutions to navigate the complex procedures of medical device regulations worldwide with reliability, trust, and premium quality.  

With years of hands-on experience, we navigate the complex world of regulatory frameworks with ease. By collaborating with external partners, we go the extra mile to ensure that your company meets the stringent requirements for medical devices submissions worldwide.

We understand how overwhelming the regulatory approval process can be, so we've got your back. Our commitment to staying ahead of the ever-changing regulatory landscape sets us apart. We're not just experts; we're your reliable allies in the fast-paced world of global and local medical device regulations. 

Trust us to simplify the journey for you!

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.

Industry Support

Looking to get in touch with a regulatory expert for ensuring compliance with the latest regulations pertaining to medical devices?


We'd love to support you – Get in touch!

Get the latest new around the world in Medical Devices World! 

spalten3
default image for news
MEET US AT

MedConf 2024

16 - 18 Apr 2024
in person in Munich, Germany

MedConf 2024

MEET US AT
16 - 18 Apr 2024
More information on
Medical Devices
Join our workshop and talk
in person in Munich, Germany

Biocompatibility Testing In Medical Devices 2024 Conference

Join our workshop and talk
21 - 22 Mar 2024
More information on
Medical Devices
MEET US AT AND JOIN OUR TALK
in person in Berlin, Germany

Annual Medical Device Biocompatibility Conference

MEET US AT AND JOIN OUR TALK
16 - 17 Nov 2023
More information on
Medical Devices

FAQs

Biological safety or biocompatibility evaluation refers to the assessment and management of risks associated with the biological safety of medical devices. It is essential to ensure that medical devices do not cause harm to patients and healthcare workers. Compliance with biological safety standards and regulations is crucial to obtain regulatory approval and market acceptance for medical devices.

A biological evaluation plan outlines the systematic approach for assessing the biological safety of a medical device. It is essential for regulatory compliance as it ensures that the evaluation process follows established standards and guidelines, such as ISO 10993. A well-developed plan demonstrates the safety of the device to regulatory authorities, facilitating market access.

 

Toxicological assessments evaluate the potential harmful effects of substances released from medical devices in the patients. They can be conducted on the composition  (when available) or on the results of extractables/leachables studies.

Study concept management involves defining the objectives, scope, and requirements of the study. All the requirements are communicated to the laboratory to receive a quotation and prepare a study plan. Study monitoring ensures that the study is conducted according to the predefined protocol and standards. We oversee the entire process, from selecting the laboratory to monitoring the progress and ensuring that all relevant data is collected and analyzed.

The timeframe for completing biological safety and toxicological evaluations varies depending on the complexity of the device and the specific requirements of the project. However, we strive to provide efficient and timely services, ensuring that our clients receive comprehensive evaluations within a reasonable timeframe.  

Usual challenges include navigating complex regulatory requirements, interpreting ambiguous guidelines, selecting appropriate testing methodologies, and addressing unexpected findings during the evaluation process. Our consultancy services help companies overcome these challenges by providing expertise and guidance throughout the assessment process.

Key regulations and standards include ISO 10993 for biological evaluation, ISO 18562 for biocompatibility of breathing gas pathways, ISO 7405 for dental materials, and regional regulations such as those from the EU, MHRA, or US FDA. Compliance with these standards is essential for obtaining regulatory approval for medical devices.

Our consultancy services provide expertise in developing tailored biological evaluation plans, selecting appropriate testing methodologies, interpreting results, and ensuring compliance with regulatory requirements. We guide companies through every step of the assessment process, from initial planning to final reporting.

Our consultants have extensive experience and expertise in biological safety,  and toxicology. They hold relevant academic qualifications and certifications and stay updated on the latest developments in these fields through continuous education and training. A certified toxicologist is always involved in all tasks.

The process typically begins with an initial consultation to understand the client's needs and requirements. We then develop a customized proposal for conducting the assessments, which may include material characterization, toxicological risk assessment, and biocompatibility testing. Throughout the process, we provide ongoing support and guidance to ensure successful outcomes.

A zoonosis risk assessment evaluates the risk of transmission of diseases from animals to humans through medical devices containing materials of animal origin. It is required as part of the risk management process for such devices to ensure that any potential risks are identified and mitigated effectively.

We have strict protocols and procedures in place to ensure the confidentiality and security of client information and sensitive project data. This includes restricted access to information, secure data storage systems, and non-disclosure agreements with all involved parties.

Medical Devices Regulation Around the World

  • EMEA
  • USA
  • Asia Pacific