Experience across medical-device categories, from software and monitoring to imaging and drug delivery.
Every device brings its own questions, from how it is used to the evidence that supports it. Experience across the areas below helps us understand that context and work with your team on a practical way forward.
Software as a medical device, patient monitoring, and cardiology monitoring systems.
Experience includes global compliance for software as a medical device, quality systems for non-invasive patient monitoring, and evaluation of hardware and software changes in cardiology systems.
Ultrasound, automatic defibrillators, rotational atherectomy, endoscopy, and visualization systems.
Experience spans early fetal ultrasound development, diagnostic ultrasound, endoscopy and visualization, automatic defibrillators, and Class III cardiovascular atherectomy devices. The work connects product development with quality systems, submissions, and international market access.
Needle-free injection, combination drug-delivery systems, respiratory therapy, and ventilators.
Experience includes needle-free injection and combination drug-delivery systems, ventilators, and respiratory therapy. Participation in standards working groups covers needle-free injection systems, aerosol drug delivery, and emergency and home-use respirators.
Single-use products, radiation treatment, and mobility assistance.
The practice also draws on background experience with disposable products, active and non-active devices, and treatment systems. Fit for a specific technology is discussed before work is agreed.
Examples of technologies supported through product development, regulatory affairs, and quality work.
Illustrative device photograph
Early work with automatic defibrillators adds experience with devices intended for use beyond the hospital.
Technology illustration
Quality-system development and regulatory support for Class III cardiovascular atherectomy products, from a startup through commercial growth.
Technology illustration
Regulatory and quality work for needle-free injection and combination drug-delivery systems, including international registrations and standards development.
Tell us about your product, your priorities, and the question ahead. A brief, non-confidential overview is enough to begin.
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