Global Med Tech have developed, supported and released dozens of products according to the strictest standards and regulatory requirements, and that passed regulation checks on the first time. Our whole approach is regulations targeted, and we are up to date on regulations, standards and perform our initial planning, engineering and design based on this knowledge, as well as other customer specific requirements. This approach controls the development process as well as the detailed documentation and the final product quality.
At Global Med Tech we support full DHF and DMR files, which means that the whole development process is recorded into the documentation, and this enables us to pass 60601, CE, FDA in a very short time. Quality is one of our core values and we are ISO9001 and ISO13485 compliant.