Regulatory Standards Compliance

Navigating the hundreds of medical device regulatory standards that exist and understanding which ones may apply to your product is a daunting task. An experienced consultant can help you identify the standards early in the product development process as part of your regulatory strategy, so that the regulatory filings can proceed smoothly and quickly.

Shaw Quality has experience developing processes that allow medical device companies to meet the standards for risk management, usability engineering, electrical safety, biocompatibility, sterilization and software development.