From initial strategy to project recovery, including all steps in between, we have helped many customers gain efficiencies and accelerate their medical device development to market release. We handle all required design history documentation for a successful FDA or EU Notified Body submission. We have extensive experience with all regulatory compliance aspects from premarket to postmarket, and we work with all leading technologies for mobile devices, cloud/backend, AI/ML, and EHR/EMR integrations. We bring our combined experiences to provide you with invaluable insights and ensure a more predictable journey.explore
Consumer health, critical care, transplants, patient monitoring, bio-sensors, and wearables.
Devices and systems for infusion, respiratory, OCT intraocular, and ingestible.
Point of care, lab systems, consumables, IVD, EKG monitors, hardware and software.
SaMD, digital health, IoT, AI/ML, rare disease, user experience, and design thinking.
SaMD applications, or Prescribed Digital Therapeutics (PDT), are FDA approved software-based medical devices, prescribed by a clinician, that are intended to treat or prevent diseases and are typically used with non-medical hardware connected to virtual networks.
Examples of SaMD applications include:
Software-based medical devices that are intended to prevent, manage, or treat a medical condition.
Medical device manufacturing is a highly regulated industry because of the potential these products can cause or contribute to adverse effects on patients' health and safety. Both premarket and postmarket regulatory requirements from design controls to post market surveillance assure that patients and providers have timely and continued access to safe and effective, secure, and high quality medical devices. The regulations are also intended to facilitate reliable and predictable medical device innovations by enabling manufacturers to balance benefit-risk data collection between the premarket and postmarket phases to fully demonstrate reasonable assurance of safety and effectiveness of a device when used in real-world clinical practice.discover more
Embedded medical systems consist of hardware and software customized for specific functions in medical devices. These technologies allow patients' health to be monitored and managed frequently each day. Many medical devices these days are connected to a mobile device app or the healthcare provider's network to enable remote monitoring and configuration. They can range from glucose monitors to implantable pacemakers, desktop CPAP machines, and a variety of biomedical sensors. With biomedical applications, embedded medical systems allow doctors to remotely monitor patients' health and make diagnoses and treatment decisions through telemedicine and other remote cloud-based systems.
It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. And for over two decades now, it is also well understood that risk management is an integral and valuable component of an effective quality management system, where the evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and the level of effort, formality, and documentation of the risk management process should be commensurate with the level of risk. Accordingly, product safety and cybersecurity risk management is part of FDA Quality System Regulation (QSR) in 21 CFR Part 820, as well as EU MDR 2017/745 Articles 10 § 2, 20 § 9, and 83-86. Applicable international harmonized standards for medical device and health software risk management include EN/ISO/IEC 14971, EN/ISO/IEC 62366, ISO 81001-1, IEC 81001-5-1 and ANSI/AAMI SW96.discover more