bob-lRobert Labaczewski
Associate Director Quality Group


Robert has over 18 years of experience in quality systems and engineering in the Medical Device Industry, with extensive knowledge around QSR 820 and ISO 13485. Robert is currently the Associate Director – Quality Group at Bracco Diagnostics, Inc., responsible for the medical devices and all medical device quality systems in the US. Robert earned a B.S. in Biology from Providence College, is a certified Quality Auditor, and is currently in the process of getting a Lean Six Sigma Green Belt certification. This is Robert’s third time presenting at this conference.


Robert will be one of the distinguished speakers at the 6th Annual Diagnostic Quality Assurance Conference.


Why is the 6th Annual Diagnostic Quality Assurance Conference important for quality assurance executives?
It gives an opportunity to share insights and strategies on several hot topics in the industry. The quality landscape is always changing and seeing how other organizations are dealing with these changes adds value.


What initiatives are on the horizon at your organization for the quality assurance department in 2015-2016?
UDI implementation, Lean initiatives, and keeping up with the constant regulations and standards updates.


Are there any sessions or topics you’re looking forward to discussing at this year’s conference?
I will be presenting on document management systems, but looking into how to streamline risk management activities sounds very interesting, especially with the recent changes to ISO 14971 and the implementation of safety assurance cases.


How has your organization improved risk management within the quality assurance department?
We have worked extensively with our Notified Body to ensure compliance with the modified ISO 14971 requirements. We have also started to create safety assurance cases for new products. We evaluate our formalized risk management documents for every product change.


How do you believe that advanced technologies impact quality management systems?
It can definitely help better facilitate processes, but it also presents a challenge on how certain applications can be controlled and monitored.


What are your/your team’s goals for the coming year?
To continue to improve our systems while maintaining a high level of compliance.


What are three key areas to examine when selecting quality management systems?

  • Compliance
  • Flexibility
  • Ability to Control


And finally, what keeps you up at night?
There have been new regulations and standards implemented (ex. UDI, RoHS, REACH), modifications to existing standards,  and many more modifications coming. It feels that sometimes it is impossible to keep up with everything.