Technology and safety for medical devices
Dedicated to healthcare industry innovation, we leverage decades of advanced technical, regulatory, and clinical expertise to help clients manage regulatory and global market access issues and address emerging connected device risks. We help to ensure that medical devices are safe to deploy for use in an increasingly patient-centric and connected environment and support clients in solving critical health, safety, security, and interoperability challenges.
We also offer world-class industry compliance training for health and life science companies and healthcare providers so they can meet evolving global regulatory expectations.
Medical Devices Evaluation, Testing and Certification
Healthcare technology and medical devices are constantly evolving to improve accuracy, patient safety and patient wellness. This rapid progress also leaves these devices increasingly susceptible to quality, safety and cybersecurity issues. We offer safety and compliance testing and training to help address these and many other issues facing the healthcare device industry.
Our expert engineers prioritize wellness and safety through our testing services. We offer total product lifecycle testing, risk management evaluations, and quality management support for healthcare devices. These tests will examine products and facilities for:
- Electrical safety
- Electromagnetic compatibility (EMC)
- Biological evaluation, Microbiological tests, and sterilization services
In addition, we offer safety management software and a training program (PURE) to help operations better manage and understand products safety requirements.
Healthcare device regulatory compliance can be extremely difficult to navigate. We work with global manufacturers, developers and end users, from design through market release, to help keep your products compliant with local regulations. Our worldwide labs provide localized testing services to cover international standards though the US, EU, Brazil, Japan, China, Australia, and many other regions. These standards include:
- UL 2900 cybersecurity
- IEC 61010
- IEC/ AAMI 60601
- ISO 14971
- ISO 13485
- CE Mark
INMETRO Certification Requirements
We can provide both test reports that meet Brazilian and other countries’ requirements. You can rely in our global structure and labs around the world. We can also provide complete testing to applicable International Electrotechnical Commission (IEC)/NBR 60601 collateral and particular standards, including electromagnetic compatibility (EMC) and software evaluations as required by National Institute of Metrology, Standardization and Industrial Quality (INMETRO).
The IEC 61010 standard addresses the safety of laboratory, inspection, and measurement equipment. This includes electrical equipment for measurement and control in laboratory use. Types of laboratory equipment covered by the IEC 61010 family of standards include:
- Test and measure equipment - Tests measure, indicate, or record electrical or non-electrical quantities
- Laboratory equipment - Measures, indicates, monitors, analyzes or prepares materials
- Computing equipment - Part of the equipment standard or designed exclusively for the equipment
Electrical Medical Device Certification
We offer a full suite of services aimed at helping our customers with electrical medical, laboratory and other healthcare related devices. Such as:
- Testing, certification and standards-based compliance testing/evaluation
- Early design reviews
- Gap analysis
- Documentation review
- Custom testing
Sterilization and Microbiology Testing for Medical Devices
Sterilization and Microbiology Testing for Medical Devices is important as medical devices contaminated with pathogens may be a source of infection for humans. According to the Medical Device Directive, devices must be designed and manufactured in such a way as to eliminate or reduce the risk of infections to patients and other users.
Medical Device Cybersecurity Certification
The UL CAP Evaluation reviews documentation related to the processes of medical device cybersecurity and network connected device cybersecurity. The UL CAP Certification is based on industry initiatives, regulations and best practices related to cybersecurity.
The UL Cybersecurity Assurance Program (UL CAP) for Network Connectable Components of Healthcare and Wellness Systems is a suite of solutions that helps verify compliance with requirements which validate that your product and systems offer a reasonable level of protection against risks that may result in unintended or unauthorized access, change or disruption. It is based on the following FDA approved standards:
- UL 2900-1:2017 Software Cybersecurity for Network-Connectable Products, Part 1: General Requirements (1st Edition)
- UL 2900-2-1:2017 Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems (1st Edition)
In today’s healthcare landscape, protecting and managing an individual’s data are key components of patient safety and health. We are dedicated to protecting patient and employee data through testing for healthcare systems and offering software tools to help decrease your administrative burdens so you can focus on important day-to-day provider tasks. Through our diverse array of offerings, we help enable you to spend more time with your patients.
Healthcare data protection
Connected and handheld medical devices are commonly used to collect and store patient data. We offer cybersecurity risk management solutions that help safeguard Personal Health Information (PHI). We also provide occupational health and safety software, electronic medical records (EMR) and patient health software solutions. We deliver tests and training for:
- Our UL 2900 cybersecurity standard
- Interoperability / usability
- Employee health records
Occupational health management software
Clinics, hospital systems, and other healthcare facilities need to track and manage large volumes of vital patient and employee data every day. They also need to communicate effectively with organizations who trust them to manage their employee health. It is increasingly critical for provider team members to be able to spend time with patients while managing employee health and medical compliance and improving organizational productivity. These providers use our occupational health software solutions (OHM, SYSTOC®, PureOHS™) to help streamline administrative efforts for areas including:
- Vaccination and program management
- Case management and return-to-work
- Patient scheduling and billing
- OSHA and CDC internal compliance
Pharmaceuticals and Biotech
The evolving pharmaceutical and biotech marketplace demands quality assurance and transparency. We offer a complete portfolio of services to meet these demands including validation, usability and testing services for healthcare packaging, combination products, and over-the-counter (OTC) products.
Packaging is viewed as the first line of defense for healthcare products. We provide packaging validation and stability studies for product transport and proper storage. Through a combined stability and packaging validation study, sealed products are tested to ISTA, ASTM, or the ISO 11607-1 shelf-life standard. The tests performed include:
- Dye test for seal integrity
- Sterility tests
- Shelf-life test
- Peel test, burst test and bubble test
- Air permeability test
- Transportation and packaging system validation
We offer potency and purity testing for OTC and pharmaceuticals, as well as pharmacopeial testing to U.S. and international standards. We test for:
- Potency and purity, including impurities
- Quality assurance
- FDA and other regulatory standards
- Ingredient validation – label reviews
- Benchmarking analysis
To complement these testing services, we deliver learning management systems trusted by the FDA and e-learning content. Our training incorporates global processes for new drugs developed in conjunction with the FDA. Our ComplianceWire® learning management system was designed specifically for highly regulated industries, and is compliant with 21 CFR Part 11 and EU Annex 11 validation requirements.
We operate in more than 100 countries, and our reports and certifications are recognized and accepted around the world. We have helped to set more than 1,600 Standards defining safety, security, quality and sustainability. Our global reach and local presence allow us to deliver innovative, customized solutions to streamline testing and help simplify the certification process. Leveraging our expertise during the development process can help you avoid costly errors in the design phase and speed time-to-market.
Our expert engineers prioritize wellness and safety through our testing services. We offer total product lifecycle testing, risk management evaluations, and quality management support for healthcare devices. We offer total product lifecycle testing, risk management evaluations, and quality management support for healthcare devices.