SDRAN - TUV Joint April Event: Medical Device Single Audit Program – one audit multiple market acce
Wednesday, April 12, 2017
Medical Device Single Audit Program – one audit multiple market access
Royth von Hahn Ph.D.
Vice President, Medical & Health Services
TÜV SÜD America, Inc.
Director of Regulatory Affairs
Wednesday, April 12, 2017
5:15 – 6:00 PM Registration & Snacks
6:00 – 6:05 PM Welcome and Announcements
6:05 – 7:00 PM Program Presentation
7:00 – 7:20 PM Q & A
BD (directions on last page of this flyer)
6055 Lusk Blvd San Diego, CA 92121
The program will give an introduction of the Medical Device Single Audit Program (MDSAP) and also draws a bigger picture on how MDSAP fits into the various regulatory changes in the medical device and IVD market. MDSAP has gained international traction in the market especially in light of the announcement of Health Canada to make MDSAP certification mandatory from Jan 1st 2019 for the Canadian market.
The presentations will give different perspectives on the questions of objectives and requirements as well as preparation for MDSAP transition from the point of view of the manufacturer as well as from the auditing organization. Especially the differences in audit planning, execution and follow up will be highlighted along the lines of real examples.
The following topics will be covered in particular:
Introduction of MDSAP in the context of other regulatory changes
Objectives of the program
Pilot phase completed
Acceptance by regulators
Resources (FDA website)
The Audit Process
Audit On-Site time calculation
Obstacles for manufacturers to implement MDSAP
Experience from the auditor’s perspective
Royth v. Hahn leads the TÜV SÜD Business Unit “Medical and Health Services” in the NAFTA region and manages the technical topics of functional safety and software for medical devices globally. He also leads the “investor’s program” with services of technical and regulatory due diligence. He started his career at the University of Bonn and a MedTech spin off/start up in the field of medical ultrasound. He was head of a test laboratory and interim professor at a university of applied sciences in Germany for the topics of signal processing, medical imaging and ultrasound technology. Prior to taking on management positions within TÜV SÜD, Royth worked as Senior Product Specialist for ultrasound devices and lead auditor for active medical devices and software. He is member of several national and international standardization committees.
Royth holds a master’s degree for physics from the university of Bonn (Germany), and industrial engineering & management in Koblenz (Germany). He also holds a PhD in electrical engineering from the University Duisburg in Germany.
Frank Pokrop is a Director of Regulatory Affairs at Becton Dickinson in San Diego. His manufacturing experience includes injectable drugs and medical devices. Additional experience includes global submissions, recall management, compliance and investigations, worldwide audit program management, training, standards management and regulatory intelligence. In his current role he is primary contact for UDI issues for BD worldwide.
Frank received his B.S. in double major of biology and political science from the University of Wisconsin-La Crosse. He is a member of ASQ, ISACA and RAPS and holds these certifications: RAC, CSQE, CISA and CPGP. Frank is also the president of the San Diego Regulatory Affairs Network (SDRAN) for 2017.
Please make your reservation early. The pre-registration due date is Monday April 10, 2017. Credit Cards are accepted on-line only. Cash and Check are accepted at the door.
On-line Pre-registration (through Monday April 10, 2017):
$20 SDRAN Member $35 Non-Member
Late Online Registration (Tuesday April 11, 2017):
$30 SDRAN Member $45 Non-Member
$35 SDRAN Member $50 Non-Member
NOTE – new location until further notice.
From the North 5: I-5 South toward San Diego Keep left and continue on I-805 South Take exit 27 toward Mira Mesa Blvd Take Mira Mesa Blvd to Lusk Blvd Turn left on to Sorrento Valley Road Stay on the road until it turns into Mira Mesa Blvd Move to the left-hand lane At the light - On the left (notice Holiday Inn Express & Chili's) Turn left on to Lusk Blvd Turn at the first right hand Turn at the first left hand (opposite Chili’s) BD, Bldg. “C” is straight ahead
From the South 5 I-5 North From the right hand lane, take Exit 27A for Mira Mesa Blvd From the right hand lanes, turn right on to Mira Mesa Blvd Move to the left-hand lane At the light - On the left you will notice: Holiday Inn Express / Chili's Turn left on to Lusk Blvd Turn at the first right hand Turn at the first left hand (opposite Chili’s) BD, Bldg. “C” is straight ahead