The Hialeah Technology Center is known for its efficiency and quality in terms of providing the best form of FDA Consulting. We help companies abide by state and federal laws all the while providing services that include regulatory testing of medical devices, software, and procedures. If you choose the Hialeah Technology Center as your FDA Consulting provider, you will benefit from the following and more.
Before marketing a medical device in the US, or reintroducing a device that has been modified, medical device manufacturers need to abide by the Food and Drug Administration (FDA) rules. If there is a a substantially equivalent (SE) product in the market, the company must submit a 510(k) given that this device is belongs to Class I, II, and in certain cases III. If the device has no SE, a pre market approval (PMA) must be submitted, given the device is a Class II or III. When the company specializes in components, a device master file (DMF) must be submitted to teh FDA as well. This can surely be a long process, limiting your companies profitability as the time from conceptualization to marketing is greatly extended.
To successfully bring a new medical device or drug to the market your company and the product itself must undergo various FDA audits and inspections. Without assistance, a company may face problems that include an unclear or inappropriate cover letter, an incorrect classification of a device (PMA or 510(k)), poor presentation of clinical trial data, misguiding advertising material, or misunderstanding of the relationships between the FDA reviewer and the company.
Upon giving us basic information about your device - intended use, substantial equivalent devices, risks and hazards, and materials - HiaTec will assist you with all aspects of compliance anywhere from device compliance to regulation and marketing. Through its knowledge of internal FDA procedures, HiaTec can help you become familiar with the FDA and ensure their expectations of the product are met. HiaTec will even create a customized training program geared towards your company's products so that your employees will be aware of FDA regulatory and quality requirements. Furthermore, HiaTec will create a quality system strategy to overcome the Quality System Regulations (QSR) / cGMP (Current Good Manufacturing Practices) guidelines so that your company is safe from facing FDA warning letters or being published in any FDA Enforcement Report.
HIATEC helps evaluate the safety performance and helps obtain FDA market approval for various types of new medical devices, which benefit companies with new business opportunities in the US and in the Latin American market. HIATEC also provides Quality Management and Regulatory assistance to medical device companies so they can stay in business and gain new customers in international markets. HIATEC helps medical device companies with international regulations and market penetration strategies.
HIATEC provides complete regulatory consulting services for Food and Drug Administration (FDA) 510(k) submissions, as well as for other medical regulatory affair needs, such as the Medical Device Directive MDD CE mark or FDA Quality Systems Regulation QSR compliance. HIATEC's regulatory, engineering, and scientific team can efficiently help you achieve FDA SE notices so your product will reach marketability sooner than ever.
In addition, HiaTec goes beyond traditional regulatory consulting giving you the advantage of an engineering team that also assists in medical product development and testing. HiaTec maintains a policy of doing things right and doing them quickly, ensuring that the submission will receive FDA acceptance as soon as possible - preventing delays in marketability and maximizing return on investment. Our team of experienced engineers who understand the product development process will work with your team to bring all these promises to reality.