RAPS 2020 Convergence

TUV USA will be participating in the Regulatory Affairs Professionals Society Convergence Virtually

Contributed by: Kristen Newhall

TUV USA is attending the Regulatory Affairs Professionals Society in September 2020.

According to their website, The RAPS is “the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics, and nutritional products.” 

Founded in 1976, their mission is to improve and sustain a competent worldwide regulatory workforce that advocates good regulatory practice and policy to progress and advance public health.

One of RAPS’ goals is to actively support professionals in the regulatory field. Therefore, when the COVID-19 pandemic quickly made it impossible for such a large gathering of people to congregate, the organizers took a different approach from previous years. This year, all the convergence activities, including the educational sessions and booths, are entirely virtual. Instead of shaking hands and speaking face to face, visitors and professionals will be conversing via video chat and the educational programs will all be broadcast. Exhibitors have virtual booths and a video link that anyone can log into to talk with a representative. Pamphlets and flyers will be replaced with PDFs and short videos. RAPS has developed a great deal to overcome the stress of transitioning such a large convention to a virtual arena. 

RAPS starts Sunday September 13, and runs through Wednesday September 16, 2020.

TUV USA, Inc. has received full recognition as a Recognized Auditing Organization under the MDSAP Program

Salem, New Hampshire -- TUV USA, Inc. announced today that as of September 5, 2018, TUV USA has received full recognition as a Recognized Auditing Organization under the MDSAP Program.

In 2014, a few third-party auditing organizations were chosen to be part of the Medical Device Single Audit Program (MDSAP). The idea was to create a program that would aid in the easing of trade barriers for international medical device companies who would wait several years just to have their applications approved to sell to a new jurisdiction. The manufacturers would then face a rigorous and exhaustive annual audit program from each jurisdiction to which they sold, sometimes taking many weeks to complete for larger organizations. MDSAP was created as a solution to this.

MDSAP represents an agreement between member countries to accept the involvement of third-party auditing organizations to improve the approval processes, reduce the workload on Regulatory Authorities, and reduce the number of audits from Regulatory Authorities that medical device manufacturers have to coordinate. To date, there are five jurisdictions involved in MDSAP: Australia, Brazil, Canada, Japan, and the United States.

This has been an exciting journey for all of us involved, and we are looking forward to seeing how the MDSAP program further develops! TUV USA is proud to be one of the few certification bodies providing the new MDSAP certification.