Phil Johnson is an experienced regulatory and quality based professional who has worked in the Medical Device, In-Vitro Diagnostic and Pharmaceutical Industries for over twenty-five years. His core expertise is in the regulatory and quality requirements for Medical Devices, Diagnostics and Pharmaceuticals. This has included the writing, implementation and maintenance of Quality systems, auditing of external suppliers and manufacturing/distribution sites and due diligence auditing.
He supports companies by providing complete business, regulatory and quality support for global market entry requirements, including the setting up of logistics and distribution networks and the license requirements for these operations. He provides regulatory and quality support to senior executives in determining remediation and restructuring requirements.
His current role based in the US, is to support manufacturers transition from the EU Medical Device Directives to the new EU Regulations for Medical Devices and IVD’s. He also supports manufacturers to implement ISO13485:2016 and prepare for the Medical Device Single Audit Program (MDSAP).