With the rapid changes in MedTech, the regulations and quality requirements also need to keep pace and address specific needs across different geographies. To do this, MedTech companies need to focus on connecting quality and regulatory to harmonize the product lifecycle.
Epredia, a global precision cancer diagnostics company, is doing just that. Epredia has consolidated four siloed systems into a single quality platform with a clear path to unify regulatory affairs and quality assurance. This harmonization helps eliminate manual efforts, reduce compliance risk and speed the total product lifecycle.
Watch this session on-demand to hear Mark Ramser, Senior Director of Global Quality, share:
- Best practices and lessons learned in Epredia's modernization journey
- How to enable greater collaboration and efficiency
- Developing plans to unify regulatory affairs and quality assurance in the future
Mark is currently the Senior Director of Global Quality at Epredia, with global responsibility for all quality-related activities. Mark was previously the Senior Global Director of Quality Assurance for the Industrial and Healthcare Materials Group at Avery Dennison. While there, he focused on harmonizing quality management systems globally to be compliant with ISO 13485, Title 21 CFR Part 820, ANVISA (Brazil), KGMP (Korea), Medical Device Single Audit Program (MDSAP) and the Medical Device Regulations (MDR).