Join Our Free Online Webinar on June 24, 2025, at 10:00 AM
DQS Slovakia invites you to a complimentary online webinar focusing on the latest developments in medical device regulations. The session will be led by Irenej Poláček, an experienced auditor and Technical Manager for Medical Devices, who will provide valuable insights into the evolving regulatory landscape.
MDR Transition Update & Notified Body Capacity: Gain an understanding of the current status of the Medical Device Regulation (MDR) transition and the capacity challenges faced by notified bodies.
Application Transfers During Transition: Learn about the procedures and considerations for transferring applications amidst the regulatory changes.
Key Challenges & Lessons Learned for Manufacturers: Discover common obstacles encountered by manufacturers and the lessons learned to navigate the MDR effectively.
Effectively Combining MDR with MDSAP: Explore strategies to integrate MDR compliance with the Medical Device Single Audit Program (MDSAP) for streamlined regulatory adherence.
Overview of UKCA Deadlines: Stay informed about the upcoming deadlines for UK Conformity Assessed (UKCA) marking and its implications for market access in the United Kingdom.
This webinar is ideal for medical device manufacturers, regulatory affairs professionals, quality managers, and other stakeholders involved in ensuring compliance with medical device regulations.
Don't miss this opportunity to stay ahead in the ever-evolving field of medical device regulations. Please send an email to [email protected] and we will provide you with the link to join the webinar.
Riaditeľ a konateľ certifikačnej spoločnosti DQS Slovakia, s.r.o. Zároveň je certifikačným audítorom treťou stranou pre normy ISO 9001 a IATF 16949. Dlhé roky spolupracoval s výrobcami automobilov (OEM) a ich dodávateľmi, kde častokrát mohol nahliadnuť do toho, čo sa skrýva za množstvom požiadaviek na systémy kvality. Umožnilo mu to lepšie pochopiť, prečo nejde „len“ o požiadavky, ale aj o filozofiu myslenia smerom k zákazníkovi. Automobilovému priemyslu sa naplno venoval už od ukončenia štúdia na vysokej škole, čo mu dovolilo nazbierať skúsenosti na pozíciách ako predstaviteľ pre kvalitu, realizácie školení a konzultácií, manažér pre vývoj až k certifikácií systémov manažérstva kvality.
