Medical device testing
Program and test medical devices for maximum reliability
Medical devices need to fulfill highest standards in terms of functionality and safety. With ESSERT Robotics, you can automate the programming and testing of medical devices – for a streamlined and reproducible workflow.
What is medical device testing?
The testing of medical devices involves assays to ensure their safe and effective use in patients. Depending on the kind of medical device, there is a wide range of testing approaches – from biological compatibility assays to performance testing. These tests are carried out to provide maximum medical product safety and must follow strict international standards issued by regulatory authorities.
With the Device Testing Solution of ESSERT’s ADVANCED Robotic Workstation, you can automate the product testing in medical device development and production, increasing traceability, efficiency, and regulatory compliance.
Medical device testing solution
Automated medical device programming & testing with ESSERT
With the Device Testing Solution of the ADVANCED Robotic Workstation, you have a quality validation management system at your disposal that helps you to automate the procedures of risk assessment, safety testing and quality assurance of medical equipment.
By standardizing processes for safety and risk management, you can lower the need for human resources to ensure that your medical products comply with the high standards in the medical device industry.
Advantages of our Device Testing Solution
ESSERT’S Device Testing Solution, based on the ADVANCED Robotic Workstation, comes with several benefits
for medical device manufacturers, making sure that medical equipment fulfills the manifold requirements in the healthcare sector.
Traceability and standardization
With automated device testing, test plans can be established and tracked, for reproducible and traceable processes.
Reduced need for human intervention
You can significantly reduce the need for human intervention in medical device testing, freeing up your staff for tasks they are truly indispensable for.
The expanded autonomy time brings more efficiency to the testing of medical devices, ultimately facilitating their market access.
The Device Testing Solution is designed to allow maximum interoperability – with existing production solutions, but also with staff. This enables humans and robots to seamlessly collaborate.
The Device testing Solution is designed not only according to ESD protection guidelines, but also according to GMP and other industry standards.
At Roche, we were looking for a modular, flexible solution for assembling different devices and found this solution in ESSERT´s automation platform. The collaboration with ESSERT was characterized by a high level of innovation and the willingness to adapt to the requirements of the pharmaceutical industry.
The robot workstation impresses with its flexibility, scalability and integration of state-of-the-art camera technologies.
Why and where is medical device testing necessary?
Medical device testing is a pivotal step in guaranteeing the safety and efficacy of a wide array of healthcare products. These tests are the bedrock of patient well-being and an imperative aspect of international standards, meticulously enforced by regulatory authorities.
From complex imaging devices like MRI machines and pacemakers to everyday items like syringes and bandages, a vast amount of medical equipment undergoes rigorous testing. Ensuring that these products meet exacting standards is not only a legal necessity, but most of all essential to ensure patient safety.
Types of medical device testing
Medical device testing spans a range of diverse assessments.
These include, among others, biocompatibility testing to assess compatibility with the human body, chemical characterization to ensure product safety, environmental monitoring for reliable performance under various conditions, and usability and life cycle evaluation.
Environmental monitoring within the context of medical device testing evaluates the device's performance under various conditions, such as temperature, humidity, and pressure.
This testing ensures that medical devices can consistently and reliably function in diverse healthcare environments, maintaining their effectiveness and safety.
Sterility testing is a vital part of ensuring the safety of medical devices.
This process involves the examination of products for the absence of microbiological contamination, including the assessment of bioburden and antimicrobial properties.
The goal is to confirm the sterility of medical devices, safeguarding patient well-being and preventing infections.
Chemical characterization of medical devices is an evaluation process that evaluates the toxicology of materials used, e.g. by detecting unwanted extractables and leachables.
This analysis ensures that the device materials are free from harmful substances and do not release potentially hazardous compounds into the body.
Biocompatibility testing and biological evaluation
Biocompatibility testing assesses how medical devices interact with the human body.
This evaluation encompasses both in vitro and in vivo assessments to ensure that devices are safe and well-tolerated. In vitro testing involves studies conducted outside the body, while in vivo studies examine the device's performance within living organisms.
These tests are essential for ensuring the compatibility of medical devices with human biology.
Usability and life cycle evaluation
Usability and life cycle evaluation is crucial for assessing medical devices, especially combination products, which merge various components for therapeutic use.
It encompasses examinations such as EMC testing to ensure electromagnetic compatibility, but also software validation.
These evaluations consider the device's entire life cycle, ensuring functionality, safety, and compliance from packaging and labelling through use and disposal.
Regulatory standards to be considered
Compliance with regulatory standards is paramount in the medical device industry. These guidelines are essential to ensure safety and quality on international markets. Here is a list of some of the key regulatory requirements and standards:
- FDA (United States)
- MDR (Medical Device Regulation) (Europe)
- ISO (e.g. 13485 or 14971)
- IEC 60601-1
- ASTM and AAMI standards
Advantages of automated medical device testing
Automated medical device testing offers a host of benefits, streamlining the evaluation process and enhancing product quality.
With reduced human intervention and standardized workflows, it ensures safety, reliability, and compliance, ultimately driving efficiency in the medical device industry.
Increased safety and reliability
Automated medical device testing is pivotal for enhancing safety and reliability through standardized processes. It ensures consistent and accurate testing, reducing variability and minimizing the risk of errors.
With standardized workflows and processes, medical devices are rigorously evaluated, promoting their safety and efficacy.
This precision in testing fosters greater confidence in healthcare products, upholding the highest standards of quality and patient safety.
Protection for staff
Automated medical device testing provides a shield of protection for staff in several ways. Firstly, it spares them from potential exposure to hazardous substances that may be involved in the testing process, safeguarding their health and well-being.
Secondly, it reduces the physical strain associated with repetitive tasks and movements. Automation eliminates the need for staff to perform monotonous, physically demanding actions, preventing workplace-related injuries and health concerns.
This not only prioritizes employee safety but also enhances their overall job satisfaction and productivity in a controlled and safe testing environment.
Streamlined and consistent device testing
Automation in medical device testing offers the advantage of reduced down-times. The integration of automated systems ensures continuous testing, eliminating the need for extended manual setup and adjustments between tests.
This results in a more efficient testing process, where medical devices can be evaluated quickly and consistently.
Such streamlined and consistent testing not only expedites the development and production of medical equipment but also enhances overall productivity, ensuring that devices meet the highest standards while minimizing delays and disruptions.
Automated documentation for transparent processes
Automation in medical device testing facilitates transparent and efficient documentation processes. With automated systems, data capture and reporting become streamlined, reducing the risk of human errors in record-keeping. This not only ensures compliance with regulatory standards but also provides a comprehensive and easily accessible record of testing procedures.
Automated documentation enhances transparency, making it simpler for stakeholders to track and understand the entire testing process. It promotes accountability, facilitates quality control, and ultimately contributes to the production of reliable and safe medical devices in the healthcare sector.
Reduced need for human resources
In times when the recruitment of highly trained staff is increasingly challenging, the automation of medical device testing emerges as a strategic solution. The aging population's growing need for pharmaceutical products necessitates the efficient utilization of human resources.
Automation minimizes the demand for extensive human involvement in testing processes, allowing skilled professionals to focus on more specialized tasks and addressing the shifting demographics in healthcare. This not only optimizes resource allocation but also ensures the continuous production of high-quality medical devices, meeting the evolving needs of an aging population.
Automated medical device testing with ESSERT Robotics
Medical device testing with ESSERT Robotics allows you to access the manifold benefits of automation in the manufacturing process of medical equipment. The extremely versatile and scalable Device Testing Solution enables you to effectively test and evaluate medical devices in production settings where quality goes over quantity – e.g. in HMLV manufacturing.
ESSERT’s automated device testing system is based on ESSERT OS – an operating system that streamlines testing processes and lets you monitor them in real-time. Additionally, via ESSERT OS, you can easily modify testing procedures, based on the changing requirements in the medical device manufacturing industry.
ADVANCED Robotic Workstation – the base for our Device Testing Solution
Based on the ADVANCED Robotic Workstation as an extremely flexible automation platform, ESSERT’s Device Testing Solution helps you to streamline medical testing procedures. It supports you in efficiently ensuring that your products are safe, effective, and comply with high regulatory standards.
With ESSERT Robotics, you can minimize the need for manual intervention in repetitive tasks, reducing the need for human resources and enhancing reproducibility and traceability.
MicroFactory – for streamlined end-to-end processing
Assembled by combining the strengths of multiple ADVANCED Robotic Workstations, the ESSERT MicroFactory is able to automate the entire production process of medical devices. It can automatically carry out complex yet repetitive procedures, freeing up your qualified staff for tasks where they are indispensable at.
The modular setup of the MicroFactory enables you to quickly modify the production process, allowing you to adapt single production steps without the need to rearrange the entire workflow. This adds to the flexibility that the MicroFactory can bring to medical device manufacturing.
Frequently Asked Questions
What are the ISO standards for medical devices testing?
What is biocompatibility testing?
What is medical device certification?