Defining Your Regulatory Strategy Is Key
Our team has decades of experience helping medical device companies make sense of global regulatory landscapes in countries and regions all over the world. Whether it is in the US, EU, Canada, or elsewhere, we take the guesswork out of deciding which approval pathway is best for your device.
A regulatory strategy will include the interpretation of the country-specific regulatory requirements including:
- Product code and regulation number determination
- Classification determination
- Identification of applicable standards and guidance documents
- Confirmation or identification of potential predicate devices
- List of applicable tests
- Premarket pathway strategy
- Quality system requirements
- Claims and labeling review or guidance.
Sterling can help.
A regulatory strategy is the first step in the long journey of bringing your device to market. We’ll help you navigate the complex regulatory maze and bring your medical device to market quickly and cost-effectively. Contact us now! Let our experts guide you through this important process, every step of the way.
About Sterling Medical Devices
Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.
