Regulatory Strategy and Submissions
Speed To Market, Inc. (STM) has experience in most primary markets and can assist your company with planning and implementing your regulatory strategy and product submissions in a fast and cost effective manner.
Regulatory Strategy
Regulatory strategy development requires insight into your current product lines, and foresight to streamline regulatory paths for your future product lines. This includes:
- effective and efficient compliance with regulations
- determining the most appropriate regulatory classifications
- minimizing submission development and review times, and costs
Product Submissions
STM has experience with a wide variety of domestic and international submissions including the electronic submissions to the appropriate regulatory agencies:
- U.S. FDA premarket notifications (PMNs) also known as “510(k)s”
- U.S. FDA premarket approvals (PMAs)
- EU technical documentation
- Canadian product licenses
- Australian technical documentation
Other Services
STM offers assistance with other areas of U.S. quality and regulatory as well:
- authorized representative
- certificates of foreign governments
- device listing
- establishment registration
- export certificates
- small business qualification
- US agent
Let our medical device industry experts assist you with your company’s market access! If your regulatory needs are not specifically listed, please contact STM to find out if we can assist you with your regulatory needs.