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.
A Free Consultation
Please call us at +1(650) 336-8641 and leave your name and number.
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
Asia holds many opportunities for medtech companies. Japan, for example, is the second largest medical device market which equals €23.1 Billion or 11% of the total world market. Haio Fauser is the Principal Contractor of acroMIS and has worked in Asia for many years. Whether you are entering the Asian market place for the first time or introducing a new device, he implements your Asia Pacific commercialization strategy and develops sales channels according to your qualification criteria. Haio is a start-up specialist for global strategies of medical technologies and he makes sure that his clients are hitting clinical and commercial milestones early.
Many Asian distributor and medical technology companies gain bandwidth and momentum with an evaluation of U.S. or European medtech opportunities for mutual gain.
Haio provides actual in-country support for Asian business development specialists with interest in cutting edge U.S. medical technology.
acroMIS International Commercialization
Pick up the phone (1 650 336-8641) or email Haio (info@acroMIS.com), get your initial questions answered and see if you’d like to work with him. Contact Haio and he’ll get in touch with you to set up a time for an initial introduction and a phone call.