Complaints Handling, Adverse Event Reporting, and Recalls call for an integrated approach

Medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other generatedesign.com The new ISO version the ISO recognizes this fact. The disparate requirements of each regulatory system make it necessary for manufacturers to identify their roles as well as the regulatory requirements for that role and then incorporate them into their Quality Management System. The various jurisdictions however deal with post…