The current health care environment asks for medical devices which are designed to accomplish one or more of the following surgical goals: Less pain and patient discomfort; Faster recovery and return to normal life; Increased effectiveness and safety; Fewer complications and follow up costs; Reduced device and procedure costs; Devices that reduce the need for inpatient hospital stay.
With our expertise in implementing first international uses we support your clinical evidence in successfully demonstrating two things: 1. That your device achieves its intended performance during normal conditions of use. 2. That the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of the intended performance.
After a trial site and author is selected, the development of a clinical data packet starts. Goals are usually to articulate the medical necessity and a cost impact model as well as billing guide. Once the conformity assessment process leading to the marketing of the medical device has begun, new clinical safety and performance
information about the device is obtained during its use. This information is fed into the ongoing risk analysis and may result in changes to the Instructions for Use.
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In order to obtain the necessary approvals for international markets it is vital to understand and interpret the regulatory requirements. Identifying the required regulatory standards early on in the product development process saves valuable project time...
The Right Partner For Evidence Building.
We are experienced in working with developmental and later stage medical device company. Many U.S. device companies gain bandwidth and momentum with an international product evaluation such as the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device.
We help you to move rapidly, efficiently and safely into early uses and first clinical trials. We provide actual in-country implementation support in international medical markets. acroMIS implements effective clinical development programs for early uses and international adoption of your device.
Are you considering launching your medical technology outside the U.S.? Many can provide advice, but few can make it happen. We do 10% consulting and 90% actual implementation. To learn more please call (650) 336-8641 or send an email to: email@example.com