Medical Device Regulations
The number of medical device regulations you must comply with during product development vary depending on many factors including the country where the medical device is being developed and the kind of device being developed. The pathway from product design to product launch for a new medical device is often unclear and the number of challenges and questions often increase as medical devices become more complex. Generally, medical device regulations are based on risk. Our regulatory consultants have the expertise to help your medical device meet the many challenges of medical device regulations during the approval process, for products in the U.S., Europe, and Canada.
Our consultants are familiar with US FDA and international medical device regulations, are well-respected by the FDA and international regulatory bodies and have an excellent rapport with regulatory agency leaders and reviewers earned through years of professional experience. With Aptiv Solutions as your partner, you will gain a deep understanding of the medical device regulations and requirements applicable to your device, often beyond what is available in published guidance documents and other materials.
We will work with you to design and implement a competitive and cost-effective regulatory strategy, prepare and submit a “reviewer-friendly” marketing application, and serve as your liaison from start to end, helping you to prepare the necessary documentation, respond to questions and negotiate with regulatory agencies quickly and effectively.