RAPS NY/NJ Chapter: An Update on the Medical Device Single Audit Program (MDSAP)

When:  Sep 8, 2016 from 17:30 to 21:00 (ET)

8 September 2016
5:30-9:00 pm    
The Bridgewater Manor
Bridgewater, NJ

Come engage with professionals from your local regulatory community to hear an interactive presentation on the Medical Device Single Audit Program. The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations (Certification Bodies) performing regulatory audits of medical device manufacturers’ quality management systems. Termed the Medical Device Single Audit Program (MDSAP), the requirements will be applicable to regulatory authorities, as well as third-party organizations that conduct such audits. Join us for this interactive presentation on the on the MDSAP by Tamas Borsai, division manager of non-active devices for TÜV SÜD.

This meeting is sponsored by the RAPS New York/New Jersey Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals. A dinner buffet will be available to all meeting participants. Attendees who hold the RAC may claim two RAC recertification credits.

Date/Time:
Thursday, 8 September 2016
5:30–6:30 pm     Registration Check-in, Networking and Dinner
6:30–8:30 pm     Speaker Presentation
8:30–9:00 pm     Q&A Session

Location:
Bridgewater Manor
1251 Routes 202 and 206
Bridgewater, NJ 08807

Get directions online or call +1 908 658 3000

Registration:
Prior to 2 September
RAPS members: $70             Nonmembers: $85

On or after 2 September
RAPS members: $80             Nonmembers: $95

» Registration Form (PDF) - for registration by mail or fax

You can also register by calling +1 301 770 2920 ext. 200.

Speaker:
Tamas Borsai, is a division manager of non-active medical devices at TUV SUD America Inc. Borsai has over 15 years of experience in auditing medical devices manufacturers in the US, Europe and Asia. In the past he held positions as lead auditor, technical certifier and country manager. Much of his technical expertise is focused on active medical devices as a graduated electric engineer and IT expert.

Local Contact:   
Linda Bowen, RAC, FRAPS, chair, RAPS NY/NJ Chapter

RAPS Contact:
Wesley Carrsenior manager, chapter and volunteer relations, RAPS