Regulatory Affairs

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At Sterling, we know all there is to know about the comprehensive requirements mandated by dozens of regulatory bodies worldwide.

Our Regulatory Affairs services include:

FDA Premarket Approval

We’ll help you comply with the strict regulations mandated across the medical device industry, so you can get your product to market faster. Whether you need help with regulatory strategy, device classification, FDA human factors documentation, or premarket clearance and approval, we’ve got you covered.

FDA Post-Market Surveillance

Our regulatory experts will help you meet post-market surveillance (PMS) requirements to ensure the continued safety and effectiveness of your device in the real-world setting.

We also offer advanced expertise in the following areas:

• CE Premarket Approval
  We’ll help you identify and address key CE Mark requirements, so you can get your device to market faster with less confusion.
• CE Post-Market Surveillance
  With a complex understanding of the legal and regulatory requirements for marketing products in the EU, our team will guide you through the CE post-market surveillance process to ensure your device is safe and effective in the real-world setting.
• International Regulatory Requirements
  Sterling’s team of regulatory strategy experts will help you identify and address key international requirements for your device.
• Medical Device Risk Management
  Whether you need to design a new product or improve an existing one, your medical device risk management process must be rigorous, especially if you are trying to gain FDA and CE approval. Leave it to us.
• FDA US Registered Agent
  If you manufacture, prepare, propagate, compound, or process a drug or device outside the U.S. that’s imported into the U.S., we can act as your official US agent, serving as a liaison between your organization and the FDA.
• Medical Device Clinical Research and Consulting
  Without the right resources to manage the complex process for the regulatory review and approval of your medical device, you run the risk of delays and rising costs. We’ll do it for you.
• Usability Studies
  With advanced expertise in medical device usability testing, we’ll help ensure the device you build works as intended for the consumer while meeting the ISO 62366-2015 and IEC 60601-2022 standards and FDA Guidance for Applying Human Factors and Usability Engineering to Medical Devices.