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Compliance to regulatory requirements for medical technology can be confusing, especially during initial development. You may know that regulatory authorities, such as the US FDA, have oversight of medical devices. But you may not be clear on what exactly needs to be done and when it needs to be done.

Regulatory frameworks are also evolving. As new technologies enable new health and wellness functionality, regulations and standards are trying to keep pace. Different jurisdictions can take different approaches to digital health, machine learning, artificial intelligence, 3D printing and other technology innovations. It can be a challenge to understand even basic issues like what part of the technology platform constitutes a medical device and how it will be regulated.

Common Regulatory Myths

“The FDA needs to approve all our medical devices before we market them.”

“I do not need a quality management system prior to regulatory submission.”

“Design controls mean burdensome documentation of our project efforts.”

“The FDA will evaluate what my technology can do.”