The new EU Medical Device and IVD Regulations, recently published in the Official Journal of the European Union on May 5, 2017, have set into force a series of compliance deadlines and processes that include three- and five-year transition periods. This webinar will cover the major points in the regulations, practical tips to help industry absorb the regulatory changes, as well as timing and other considerations for medical device and pharmaceutical manufacturers as products are transitioned into compliance before the new regulations come into force.

Sarah H. Stec, Associate, Squire Patton Boggs
Phil Johnson, Senior Director, Quality Compliance Services, QuintilesIMS

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Speaker Biographies

Sarah H. Stec is an associate in the Healthcare Practice at Squire Patton Boggs (US) LLP in Washington DC. She has experience in assisting healthcare and life sciences companies understand new and evolving regulatory duties, including how those international regulations can work together as well as providing guidance on international corporate accreditation and regulatory issues. Her background in quality systems and experience with international regulators gives her a unique view on the legal and regulatory requirements for medical device, pharmaceutical, and food manufacturers.

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).

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