Course Description - Course runs 1:00pm to 5:00pm Day One; 9:00am - 5:00pm Day Two & Three (Breakfast & Lunch Included)

This continually updated course covers the changes to compliance requirements with respect to managing a medical device quality system.

Among the topics to be discussed are: EN ISO 13485:2016, the differences between it and EN ISO 13485:2003, how the projected changes in the MDD in 2017 and MDSAP may affect the application of the standard, and how the normalization of language with 21 CFR 820 redefines common definitions.

Who Should Attend

This 2.5-day course will be most valuable to medical device quality assurance professionals involved in the evaluation of compliance of their Quality Systems and independent auditors needing an understanding of the gaps in auditing and auditing process between EN ISO 13485:2003 and EN ISO 13485:2016. The course provides context for meeting the auditing requirements of ISO 19011:2011 with specific focus on the applicability to the transition to EN ISO 13485:2016.

Personnel involved in quality assurance, compliance or regulatory affairs who need to assess Quality Management Systems (internal or third-party) of the changes to EN ISO 13485:2016 will benefit from this course. Additionally, this program can be customized and delivered on-site for more-experienced personnel (including middle and upper management) to update and broaden their knowledge of the audit process.

Jim Rosa

Specialties: Medical Devices, Regulatory

Jim Rosa provides quality engineering guidance to companies for the development, management and operation of quality systems for devices.  He has 40 years of experience leading R&D and quality functions within regulated industries.  With roots in research and development and conversion to quality systems oversight later in his career, Jim provides a solid understanding and perspective from engineering and quality in bringing products to market in the medical device and IVD industries.  The blend of working with research & development and quality system function, in the EU and US, in startups and large companies provides a unique insight into the practical application of design control for medical devices.  Jim also has four patents related to medical device safety system implementations.  Jim has worked for Gambro, Intel, Reglera, Dohmen and a number of start-ups such as CeMines (IVD) and FibroTx(IVD).

Jim’s recent focus has been on Systems & Software within the medical device market, driving strategy and implementation efforts for traditional electromechanical, mobile applications, wireless applications, infrastructure software devices, and software as a device.  Additionally, Jim has taught Design Controls, V&V, and Risk Management at the University level.

Mr. Rosa has earned degrees from Colorado State University (MBA) and the Radford University (BSCS).