Regulatory Strategy Development
A well-crafted regulatory strategy considers not only international and FDA medical device regulations, but also development costs, development cycles, and profitability concerns. Aptiv Solutions will consider the current regulatory environment, relevant guidelines, and ongoing FDA and/or international medical device initiatives that could influence your regulatory pathway. Our goal is to facilitate a timely, competitive, and successful product clearance or approval.
We will consider information about your medical device, including, the device description and specifications, its intended clinical applications and labeling claims, available test data, and any literature references. We will also review information about possible predicate devices that may be similar to yours, along with standard methods, procedures and/or practices, FDA submission guidance documents, and other medical device regulations and policies that could apply to your product.
Medical Device Regulatory Strategy Experience
Our in-house consultants and project managers are well respected by the FDA and other regulatory agencies. We have excellent rapport with agency leaders and reviewers, earned through years of professional experience and almost daily interactions. With Aptiv Solutions as your partner, you will gain a deep understanding of the relevant medical device regulations often beyond what is available in published materials, directives, and FDA guidance documents.
Our goal is to provide you with a clear understanding of the types of regulatory and clinical trial requirements you will encounter as you work towards launching your medical device in the United States and internationally. We will define a strategy that will move your device along the appropriate pathway more easily and reduce the cost and time to bring your innovation from the bench to the bedside – and meet your ultimate goal of bringing safe and effective medical technology where it is needed, to the patient.