A medical device is an implant, instrument, or machine used in the diagnosis of disease, or in the cure, treatment, or prevention of disease, in humans. It is intended to affect the structure or function of the body but does not do so by means of chemical action within the body. Medical device manufacturing is governed by agencies such as the FDA and the MHRA, which expect manufacturers to adhere to stringent and established standards.
The challenges faced by today’s medical device manufacturers, when producing single-use devices, are influencing the requirement for more sophisticated manufacturing technologies. MacGregor Welding Systems is working in conjunction with medical device industry experts to lead the way in supplying a comprehensive range of resistance welding and micro arc welding technologies and is familiar with the process validation requirements required to meet FDA standards.
Cardiac pacemakers, defibrillators, guidewires, catheters, cannulae, hearing aids, brachy seeds, orthodontic appliances, prosthetics, and surgical tools are just a few of our many successful applications now being used in the manufacture of medical devices.