International device
manufacturers can find it difficult to navigate
the complex regulatory pathways necessary to access
the United States healthcare market. O’Connell
Regulatory Consultants specializes in helping
international companies, particularly small and
medium sized firms that may not have a dedicated
regulatory affairs department. The consultancy can
determine the required regulatory submission and
prepare that submission for you. The majority of
medical devices are cleared by the FDA through the
510(k) process and clearance to market your device
in the United States can occur as soon as 90 days
after the submission is made to FDA. In addition, if your device
should require another type of submission to achieve
approval in the United States including Premarket
Approval (PMA), O'Connell Regulatory Consultants can
help you to make this determination and plan and
execute your regulatory strategy. |