Safe & Secure Functional ≫ Safe & Secure Technology evolves rapidly as the population increases. The same absolute loss can be caused by either safety or security issues. Therefore, safety and security issues need to be given the right emphasis. With stronger interdependencies and more connectivity, we also become more vulnerable. We face risks from sabotage, crime, and active misuse. The safety of the individual, organizations, and society as a whole is therefore key in development. The value Globalization, technology, and digitalization offer immense possibilities. But they come with certain risks. Being and feeling safe and secure both as a customer and as a product provider is key to moving forward. Both in the sense of following standards and regulatory demands and in the sense of being able to manage threats. The challenge Product developers strive to find a balance between business goals and risk mitigation to avoid putting users, revenue, and assets at risk. This takes an increasingly greater focus which leaves less time for development and adding value in the form of features and benefits of the product. The reward As ensuring product safety becomes more complex, the rewards for having your business secured are obvious. With the entire product/service life-cycle mapped and managed, traceable sourcing, safe and secure products, services, facilities, and distribution - both digital and physical - in place, you will be able to manage your business without unwelcome disruptions and distractions. And with more customers enjoying your product. Safe & Secure - Best Practice How we achieved higher patient safety through compliance optimization Challenge Living with a chronic disease that requires continuous medical treatment is a challenge. Getting exactly the right treatment in the right dose is crucial to ensuring the patient’s safety and quality of life. The client needs our help to create an efficient and integrated production for the manufacturing of new medicine. Starting point How can we optimize the work to ensure quality, i.e. how do we create the right balance between fulfilling regulatory requirements, efficient processes and using new, modern technologies? Balancing these different perspectives and thereby ensuring patient safety and maximum production efficiency was our most important task. For maximum patient safety, the medicine needed to be traceable, all the way from the first stage of production until it reaches the patient. The process also had to comply with the strict requirements and regulations set by the authorities and the customer. Deliverables We implemented an efficient and patient safe production process of medicines. By having a compliance-optimized mindset, in-depth knowledge of the authority’s regulation and high demands on patient safety combined with our ability to integrate advanced technologies right from the start, we helped our customer to produce and offer new medicines to their patients. Value delivered Having a validated production environment for manufacturing of the new medicine, compliant with strict requirements, gives higher patient safety. It also increases efficiency through quality management and an optimized production process and reduces time to market. Safe & Secure - Best Practice How we manage cybersecurity when introducing connectivity Challenge Our world is becoming more connected, which adds huge benefits – but also substantial risks. Our client is a global supplier of heavy machinery. When adopting connectivity across their product range they needed to assure that cybersecurity risks where managed. Starting point A cross-functional team of management specialists, engineers, and cybersecurity experts was assembled, tailored for the products, technology, markets and culture of the customer. The team organized workshops to evaluate the organization's cybersecurity maturity and suggested modifications based on actual vulnerabilities, threat actors, and attack vectors. The team conducted penetration tests to identify cybersecurity weaknesses in existing products. Deliverables Objectives, processes, roles and responsibilities for managing cybersecurity aspects. Methods and tools for identifying and handling threats and vulnerabilities. An asset repository model that identifies what to protect. Recommendations for upcoming regulations and a list of priorities for further action. Value delivered The customer now has a systematic way of managing cybersecurity aspects across their product range. No need to reorganize current development processes. We help you spend more time on adding value instead of managing risk and compliance issues. Related services Battery Integration Our view Battery integration is the activity in which you define and specify several design dimensions and interfaces to ensure a safe, secure, and optimized placement and environment for the battery in its intended product or machine. Our expertise Battery form factor, controlled heating, protection from vibrations, shock, or crash to prevent damage in hazardous conditions while optimizing the performance factors and manufacturability aspects. We help you with systems engineering, robust mechanical design, and CFD calculations. CE Marking Our view CE marking indicates conformity with health, safety, and environmental protection standards for products. Our expertise We help you with CE marking in new developments and existing products or machinery when they are being updated, adapted, or changed. Cloud Computing Our view Cloud computing is the on-demand delivery of computing power, database storage, applications, and other IT services via the Internet with usage-based pricing. Our expertise We know how to build cloud-based solutions that scale without upfront investments. You focus on your incremental product roadmap - we setup the continuous delivery pipeline. Code Standards for Robust Software Our view Creating robust and durable software that withstands all types of changing external prerequisites ensures durability and product lifetime is crucial. Our expertise We guide you with industry code standards for robust software design to ensure high availability, no downtime, maximize performance, service and extend the lifetime for the product. Data Science Our view Data science is extracting insights from data sets by using software that automates the work. Our expertise We use on-edge or cloud-based platforms to develop the components needed to automatically capture, clean, transform, analyze, and visualize the result. We help you explore your data either directly in the product or in the cloud step by step with a lean startup development process that does not require large investment decisions. Functional Safety Our view New products and services with a larger degree of autonomy and less control by humans expect higher safety requirements. Our expertise We help you to develop your systems with automatic protection that respond correctly to their inputs and have predictable responses to failure. Information Security Our view Information security is about protecting confidential, private and sensitive information or data from unauthorized access. Our expertise By combining a deep understanding of your business and your customer’s data with solid knowledge about industry standards, such as ISO 27000, we can help you classify your data, identify potential gaps and take the right measures to protect it. Machine Vision Our view Machine vision refers to many technologies, software and hardware products, integrated systems, actions, methods, and expertise. Machine vision as a system engineering discipline can be considered distinct from computer vision, a form of computer science. It attempts to integrate existing technologies in new ways and apply them to solve real-world problems Our expertise We specialize in developing custom contactless measurement solutions and integration of off-the-shelf solutions into existing systems. Product Cybersecurity Our view The likelihood of a serious cybersecurity incident becomes even greater as more devices are connected. At the same time, the potential impact on society increases as we rely more on connected and automated systems, and increasingly use them to drive our cars, provide our health care, power our factories and keep us entertained. Our expertise We help you mitigate these risks in a cost-effective manner through implementation of best practices, secure design, monitoring, analysis and testing throughout the development process in accordance with Product Cybersecurity. Project Management Our view Project management often centers around delivering output on time, to budget, and with expected quality. While traditional expectations on time, budget, and quality remain, the industry is successively adopting agile methodologies, e.g. SAFe, for complex development environments. Our expertise We help you lead, plan, and execute your product development and CapEx projects to successful outcomes. Requirements Management Our view Requirements management involves documenting, analyzing, prioritizing, and agreeing on requirements so that engineering teams always have current and approved requirements. Our expertise We help you to find the right level of requirements and ensure the requirements specification. We also provide you with the means to avoid errors by keeping track of changes in requirements and fostering communication with stakeholders from the start of a project throughout the engineering lifecycle. Risk Management Our view As you develop more sophisticated products and services, managing potential risks become more critical. You need to evaluate and minimize risks with a product for people or the environment. Our expertise We help you with the systematic application of management policies, procedures, and practices to the tasks of analyzing, controlling, and monitoring risk. Robust Mechanical Design and Engineering Our view Creating a robust and durable product that withstands external stresses is crucial to ensuring product lifetime. Robust design is also crucial in advanced machine engineering to ensure high availability, minimize service, and extend equipment and machinery lifetime. Our expertise We help you create a robust and durable construction while optimizing it for weight and cost and ensuring durability and product lifetime. Systems Engineering Our view Systems engineering leads the way in requirements management and support in design thinking, development activity coordination, and life cycle aspects in complex projects. Our expertise Our systems engineering spans various industry segments, such as aircraft, commercial vehicles, robotics, software integration , and electronics engineering. Validation and Qualification Our view Products need to be validated to ensure that their specifications meet the end-users needs. Our expertise We have extensive experience of validation in pharmaceutical and medical device industries e.g. Good Manufacturing Practice, Good Automated Manufacturing Practice, and Computerized System Validation. We can help you to establish documentary evidence, demonstrating that a procedure, process, or activity - carried out in testing and then production - maintains the desired level of compliance at all stages. Contacts David Wenslandt david.wenslandt@knightec.se +46 73-740 47 01 Ankie Sjöberg ankie.sjoberg@knightec.se +46 73-143 66 06 Roger Elfving roger.elfving@knightec.se +46 73-078 29 07 By continuing to use this site you agree to use of cookies, read more:Knightec privacy policy OK Our aim is to improve people's lives through game-changing solutions. In order to achieve that we need to think in new ways and dare to explore the unproven, always with passionate teams, trust, and long-term commitments as the foundation. We strive to move forward together with our clients towards a more intelligent and sustainable world. Contact info@knightec.se +46 660 854 40 Our offices Stockholm Göteborg Malmö Sundsvall Örnsköldsvik Umeå Uppsala Västerås Linköping Helsingborg