REST ASSURED! MEDICAL DEVICE SOFTWARE Solution Overview Want to be certain that your medical device software lives up to your and your customer’s expectations and complies with regulatory requirements? Did you Know? Since 2004, all manufacturers of medical devices have to produce evidences of risk management according to the ISO standard 14971:2000, “Application of risk management to medical devices”, in order to comply with the European Directives for placing such equipments on the market. The manufacturer is required to establish documented requirements for risk management throughout product realization and to maintain records arising from risk management.   REST ASSURED! MEDICAL DEVICE SOFTWARE is a complete solution developed to produce documented evidence that  the process of validating the software components of a medical device also complies with this ISO standard. If your organisation is manufacturing or, as user, is responsible for integrating such devices in a wider operational infrastructure, choose, REST ASSURED! MEDICAL DEVICE SOFTWARE for complete confidence that the process of software validation  is based on risk analysis addressing all hazards known or reasonably foreseeable which may affect the safety and health of patients, users, or, where applicable, other persons.   Why is risk management essential for the validation of medical device software? The purpose of risk management is to identify potential problems before they occur, so that activities may be planned and executed as needed across the life of the product to mitigate adverse impacts on the quality of products compromising the safety and health of patients, users, or, where applicable, other persons. Software plays an increasingly important role in the quality and performance of medical devices. However, software is also one of the high-risk components of such devices. It is , therefore, essential to embed the validation process in a continuous process of risk management Risk management helps to focus the validation activities on critical issues making the process more effective and efficient An Effective and Efficient Validation Process To Give You Confidence   Tesnet Group’s solution consist of the following chief components: Implementation of a Risk Management Process in conformance with ISO 14971 including the sub-processes Risk analysis, Risk evaluation, Risk control, and Postproduction information feedback. Validation Planning to define validation activities, responsibilities, and procedures Review of specifications and construction, including code or configuration Testing activities, such as test planning, test design, test execution, test documentation Validation Reporting to review all the validation deliverables and activities against the validation plan and to summarize the evidences and conclusions to report that the system is validated.

REST ASSURED! MEDICAL DEVICE SOFTWARE Solution Overview Want to be certain that your medical device software lives up to your and your customer’s expectations and complies with regulatory requirements? Did you Know? Since 2004, all manufacturers of medical devices have to produce evidences of risk management according to the ISO standard 14971:2000, “Application of risk management to medical devices”, in order to comply with the European Directives for placing such equipments on the market. The manufacturer is required to establish documented requirements for risk management throughout product realization and to maintain records arising from risk management.   REST ASSURED! MEDICAL DEVICE SOFTWARE is a complete solution developed to produce documented evidence that  the process of validating the software components of a medical device also complies with this ISO standard. If your organisation is manufacturing or, as user, is responsible for integrating such devices in a wider operational infrastructure, choose, REST ASSURED! MEDICAL DEVICE SOFTWARE for complete confidence that the process of software validation  is based on risk analysis addressing all hazards known or reasonably foreseeable which may affect the safety and health of patients, users, or, where applicable, other persons.   Why is risk management essential for the validation of medical device software? The purpose of risk management is to identify potential problems before they occur, so that activities may be planned and executed as needed across the life of the product to mitigate adverse impacts on the quality of products compromising the safety and health of patients, users, or, where applicable, other persons. Software plays an increasingly important role in the quality and performance of medical devices. However, software is also one of the high-risk components of such devices. It is , therefore, essential to embed the validation process in a continuous process of risk management Risk management helps to focus the validation activities on critical issues making the process more effective and efficient   An Effective and Efficient Validation Process To Give You Confidence   Tesnet Group’s solution consist of the following chief components: Implementation of a Risk Management Process in conformance with ISO 14971 including the sub-processes Risk analysis, Risk evaluation, Risk control, and Postproduction information feedback. Validation Planning to define validation activities, responsibilities, and procedures Review of specifications and construction, including code or configuration Testing activities, such as test planning, test design, test execution, test documentation Validation Reporting to review all the validation deliverables and activities against the validation plan and to summarize the evidences and conclusions to report that the system is validated.   Together, Tesnet Group’s comprehensive validation allows you to move forward with confidence. Not only will you be certain that your application will work flawlessly and promptly, but also, that you will have a documented evidence that your application complies with the quality requirements expected by the regulatory authorities of the EU and the USA.   Proven Methodology Based on Years of Real World Experience   Tesnet Group’s REST ASSURED! MEDICAL DEVICE SOFTWARE™  solution is based upon our proprietary methodology that guarantees consistently remarkable results. Our proven methodology is based on years of real world experience in complicated testing projects. It’s a comprehensive formula that promises high quality software, shorter implementation time, and minimal risk.   Integrative Testing Automation   Automated testing tools are an integral part of the REST ASSURED! MEDICAL DEVICE SOFTWARE™   Methodology. Tesnet Group uses the market’s leading automated testing tools, augmented by our proprietary and unique SMART Functions™, which are an elaborate set of functions and add-ons that allowing us to maximize the effectiveness of market-ready tools, and to accelerate the testing process. By using automated testing tools, together with Tesnet Group’s SMART Functions™, you’ll enjoy shorter implementation time and increased test coverage, and cut human resources significantly.   A Professional Team, for Professional Results   The people you’ll be working with from the Tesnet Group team are the best quality assurance and validation professionals available who are thoroughly acquainted with the regulatory requirements in the healthcare sector. We recruit only motivated and talented individuals who agree with our principle of bringing you the peace of mind you’re looking for, and we train them rigorously and continuously. Tesnet Group’s testing team has an intimate knowledge of numerous applications and industries, ensuring the delivery of high quality solutions. To discover more about the benefits and advantages of Tesnet Group’s REST ASSURED! MEDICAL DEVICE SOFTWARE™  solution, please visit the solution’s Benefits & Advantages page.   Benefits & Advantages   Unique Solutions. Real Value.     Tesnet Group’s REST ASSURED! MEDICAL DEVICE SOFTWARE™ is designed to give you confidence and certainty that your mission-critical application will perform flawlessly. We’re not just in the business of validation. We’re in the business of giving you peace of mind.     Benefits   Your application performs flawlessly, every time. Integrative automatic testing that shortens your implementation time, increases test coverage, and saves you money. More thorough validation and quality assurance by impartial professionals whose only bias is toward your peace of mind.     Advantages   Implementation of risk management tailored to the quality requirements of your application Based on proven and real-world methodology. Join other satisfied first class customers; leading global organizations have already seen the value of our test solution. A complete solution that includes everything you need: proven methodology, a professional team, automated tools and experience in similar projects. Proprietary SMART Functions™ to maximize the power of automated testing tools. Years of real world experience in similar  implementation projects. A global leader in enterprise software testing solutions.    Methodology Highlights  REST ASSURED! MEDICAL DEVICE SOFTWARE™ Methodology Risk management as an iterative process encompassing both risk assessment and risk minimization. We identify the medical device class Device classification, established both by the European Directive for medical devices and the FDA, depends on the intended use of the device as well as the risk the device poses to the patient and/or the user. We identify potential risks Depending on the identified device class and its criticality, we perform a more or less extensive risk analysis to identify potential risks. For each identified risk/hazard, we develop a list of initiating causes which may originate from human factors, hardware faults, software faults, integration. We prefer to begin this process early in the life cycle, as requirements are specified, so that the developers of the product can utilize the outputs of the analysis to initiate measures to minimize or eliminate risks. We update the risk identification with progress in the life cycle of the product development. We evaluate the identified risks For each identified risk/hazard, we assess the severity of impact, or, to use FDA’s terminology, the “Level of Concern”, which may be classified as High, Medium, Low or Major, Moderate, Minor.  Then, we assign each identified risk/hazard a level of likelihood of occurrence of a fault causing the risk, and  a level of likelihood of detecting the fault before its impact on the safety of patients and/or users.. Using the three criteria: severity of impact, likelihood of occurrence and detection, each identified risk/hazard is assigned a risk priority.   We develop and execute a risk mitigation plan We develop a plan to eliminate or mitigate the identified risk to an acceptable level. The mitigation strategy focuses on the high priority risks.   We perform reviews to verify that the manufacturer has implemented risk control methods such as safe design (or redesign after the risk analysis), risk reduction through protective measures or adequate warning information and/or training for the user. We design and execute tests to verify that the control methods have achieved their purpose without introducing new risks/hazards We, finally, validate the application to ensure that it fulfils all specified user requirements and that all risks have been brought down to the level of minor concern.   We help to integrate postproduction information into the risk management process We help to establish procedures to review and feed back postproduction experience into the risk management loop to apply protective action and reduce risk potential in future.

BACK TO TOP