SUBMIT YOUR INVENTION TO THE FDA…
Expertise & experience drive successful FDA submission processes. Kapstone possesses both.
Our team will prepare and submit your 510(k) documentation on your behalf to address FDA requirements and anticipate potential questions, leading to on-time and on-budget regulatory approvals timelines. Our record speaks for itself. Call us now for more details.
An important element of Kapstone’s development process is to identify predicate devices and develop a regulatory strategy early in the project to minimize future costs and maximize potential for success.
Kapstone is experienced in drafting and submitting 510(k)’s as well as managing communication with the FDA. We also have established partners who are able to self-certify for CE Marking.
Post-Market Regulatory Guidance
Kapstone can help with regulatory questions that arise on products currently on the market. This includes questions related to design changes, labeling changes, recall requirements, etc.
Regulatory Compliance and Training
Kapstone can provide on-site audits to help identify gaps with FDA and CE requirements and implement a strategy to get you into compliance. We can also provide and prepare you for internal audits.