Got Your Game Plan? The OEM Playbook to Navigating Preclinical Device Testing Under MDR and ISO 10993-1

When the Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) in 2020, requirements for medical devices in Europe will present greater regulatory hurdles. In addition, ISO 10993-1, created by the International Organization for Standardization (ISO) Committee and mandated by both the FDA and MDR also introduce new requirements for pre-clinical safety device testing. Medical device manufacturers are feverishly working to navigate the changes and develop their preclinical device testing strategies to overcome what's not just a regulatory hurdle, but a business challenge.