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.

MEDPRO The Innovative Audit Processing Tool

Contributed by: TÜV NORD CERT GmbH

In response to the transition from MDD 93/42/EEC to MDR EU 2017/745, TÜV NORD CERT GmbH has developed the MEDPRO system. With MEDPRO, TÜV NORD Cert GmbH offers its customers and auditors worldwide an innovative, web-based audit tool for the simple and joint processing of audits - from audit planning to certificate release.

Available standards in MEDPRO

Currently, MEDPRO can be used to support audit and certification activities for ISO 9001:2015, EN ISO 13485:2016, MDSAP, MDD 93/42 EEC, and (in future) MDR EU 2017/745. Additional standards will be integrated moving forward.

 

MEDPRO includes a variety of features that greatly simplify the exchange of certification related information involving customers, auditors, and our project management team. An overview is provided below, showing the process steps the auditor and project manager will communicate with the customer via MEDPRO in order to jointly prepare, execute and post-process the audit activities:

Audit preparation (customer information, updates, etc.) 

• Company data n Processes & Products
• Location data

Audit planning

• Audit scheduling Audit results (audit conclusion)
• Action management

Advantages, at a glance 

• Ability to check your basic information for accuracing, inlcuding the processes, shifts and location data 
• Ability to coordinate and process the audit schedule and action plans with your auditor
• Storage of your data exclusively on TÜV NORD Group owned and certified data systems
• Protection of your data with SSL encryption

Timeline

The MEDPRO system will be made available to all customers, working with the previously mentioned standards, starting 01.10.2019.

How it works: You need an internet connection and access details for MEDPRO. Your account will be activated by your project manager after talking to you.

Further information about MEDPRO can be found on our website

If you have any questions, please contact our team.

 

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.