ImPACT Applications successfully passes the intensive Medical Device Single Audit Program (MDSAP) and obtains ISO 13485 re-certification. The audit requires full transparency with the quality management system structure, corrective action and preventive action, software development lifecycle, and IT infrastructure to ensure the public’s security and privacy.
“Choosing to participate in the MDSAP wasn’t a question for us,” said Michael Zagorski, ImPACT Applications’ Director of Regulatory Affairs and Privacy Officer. “Everything from our company procedures to staff training and privacy practices is geared towards making products people can trust.”
MDSAP was created with the goal to unify medical device audit standards to improve their safety and oversight on a global scale. As a worldwide leader in concussion management software, ImPACT Applications is well-equipped to address evolving regulatory agencies’ standards.
Along with being regulatory compliant, ImPACT Applications’ products have over 500 plus research articles containing independent and peer-reviewed studies that help healthcare providers validate the use of their concussion assessment tools.
“Passing the MDSAP is a major accomplishment and yet another example of ImPACT Applications, Inc.’s commitment to quality and compliance,” said Michael Wahlster, ImPACT Applications’ Chief Executive Officer. “This multi-country audit is necessary for an industry that sees rapid innovation and will help ensure medical device companies prioritize public safety.”
About ImPACT Applications
ImPACT Applications, Inc. is the maker of ImPACT®, ImPACT Pediatric®, and ImPACT Quick Test®, all FDA cleared Class I & II medical devices that assist in the assessment and management of concussion. ImPACT Applications also offers the FDA cleared ImPACT Baseline Test to home-based users worldwide.
ImPACT Applications products are used by most major medical centers, professional sports leagues and teams, colleges, high schools, and select military units. Since 2002, ImPACT Applications has administered more than 18 million tests to over 11 million users. Visit our website to learn more about concussion care.