HIGHPOWER’s management staff has acquired a unique set of skills over the past 25 plus years. During this time, team members worked in areas involving class II medical device production, quality assurance, validation, research and development and regulatory compliance.
We not only know the ins and outs of an IQ/OQ/PQ, but have written, filed and received dozens of 510(k) approvals from the U.S. FDA.
Although we no longer write 510(k) submissions for our clients, we are available for consulting services during the device design, development, validation and submission process.
Our new State-of-the-art facility is set up to mimic both the Central Sterile and OR Departments within healthcare facilities. This provides the perfect training environment for engineers, quality, regulatory, product managers and any personnel new to the industry. HIGHPOWER not only provides an atmosphere to learn within a classroom but also in a hands-on setting.
Let HIGHPOWER be an extension of your company by providing not only consulting with the 510(k) process but education on reusable device cleaning, packaging and sterilization validation processes. Although it’s preferred to provide training at the HIGHPOWER facility, we can also tailor packages for training at your site.
Please feel free to contact us at email@example.com with any questions you may have.