DURHAM, N.C., September 20, 2018 — Implementation of Europe’s new medical device regulations in 2017 started a transition that gives device companies up to five years to fully comply with strict new quality standards. But exactly what is changing, and why?
And how will the new MDR and IVDR rules affect the players in this nearly $800 billion worldwide market?
Nach Davé, Vice President of Global Regulatory Affairs at Premier Research, will examine these topics and more at Outsourcing in Clinical Trials Southern California 2018, September 26 in La Jolla, California. Topics in Mr. Davé’s presentation, which starts at 9:30 a.m., will include:
- Why the new regulations?
- Understanding the key changes
- Timelines and transitional arrangements
- Addressing the impact on stakeholders
- Creating a smart MDR plan
About Premier Research
Premier Research is a leading clinical development service provider that helps biotech and specialty pharma innovators — small companies with big ambitions — transform life-changing ideas into new medicines. The company applies a relentless focus on quality in the execution of global, regional, and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, dermatology, medical devices, neuroscience, oncology, pediatrics, and rare disease. Premier Research operates in 84 countries and employs 1,300 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. They are focused on smart study design for advanced medicines that transform breakthrough biotech thinking into reality.