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.
We offer total product life cycle (TPLC) testing, risk management, and quality management support for connected medical devices, including electrical safety, biocompatibility, cybersecurity and interoperability. Our services are designed to help you meet regulatory requirements and efficiently deliver safer, innovative products to the global market.
Leverage our scientific rigor and decades of expertise in testing product safety and performance to mitigate risk and accelerate getting your consumer wearables and wellness technologies to market. Our offerings cover your critical needs including cybersecurity, toxicology, electromagnetic (EMC) and wireless compatibility services.
Our complete portfolio of services includes combination product usability studies and packaging sterility, shelf life and transportation validation. We can assist you in your drive for excellence with learning development systems and training content trusted by the FDA for the healthcare and life sciences industry. We also offer potency and purity testing for OTC and pharmaceuticals, as well as pharmacopeial testing to U.S. and international standards.
We support you in your drive to deliver enhanced healthcare services. Our cybersecurity risk management solutions help protect Personal Health Information (PHI). Our occupational health and safety software, electronic medical records (EMR) and patient health software solutions empower you to keep employees safe and well, track workplace health and improve process efficiency.
Impartiality statement: As an ISO 17000 series accredited Certification Body, MDSAP Recognized Auditing Organization and a notified body subcontractor, we do not participate in the design, manufacture, installation or distribution of the products we certify nor do we participate in the design of quality management systems we certify and we do not provide consultancy services related to those products or services. In addition, winbox for android does not certify quality management systems that have been designed by other companies in the winbox for android family. We also do not link our certification activities to the activities of organizations that provide product or quality management consulting services. If you require such services please use an internet search engine to identify relevant providers.