Medical device development requires a high degree of documentation and general regulatory compliance. Historically, compliance has been met via heavy-weight documentation – management and maintenance of that same documentation places a large burden on medical device organizations. Acera Innovation strove to streamline a lengthy and arduous process via an online application allowing for multiple inputs, version tracking, development status and finally, simplification of post-market compliance.
Ackmann & Dickenson worked closely with Acera management to identify key application functionality. Features were identified, documented and prioritized. Using an agile, iterative approach, Ackmann & Dickenson quickly delivered working functionality allowing Acera the ability to load beta clients leading to invaluable feedback. That same feedback was used throughout the development process to continually educate the team and improve each subsequent iteration.
Acera Innovation delivered Pathway an integrated, online project and compliance management tool. Not only offering the same functionality as traditional word processing and project management software, Pathway is a transformational combination of product development, regulatory compliance, QMS and collaboration capabilities. Only Pathway has been built using Web 2.0 technology specifically for the medical device manufacturer.
“Acera Pathway is a transformational combination of product development, regulatory compliance and quality management system.” – Karin Gastineau, Senior Vice President RA & QA Angioscore