Sustainable claims management has become a challenge for medtech companies with the rise in regulatory requirements, new market trends, and increased content volume.
Watch this webinar with Becki Brasher, Senior Regulatory Manager, Ad Promo at Medtronic and Bassil Akra, CEO AKRA Team, for best practices to manage claims and ensure full compliance, while increasing speed to market, including:
- Advertising regulations and risks
- Ownership, substantiation, approval, and field compliance monitorization
- Do’s and don’ts for the foundation of a solid claim
- Accelerating speed to market and competitive advantage
Panelists:
Becki Brasher
Senior Regulatory Manager - Ad Promo
Medtronic
Becki leads the Global Ad Promo Center of Excellence within the Regulatory Shared Services function at Medtronic. With more than 15 years experience in the medical device industry, and more than 25 years of legal, regulatory and compliance experience, she strives to make requirements easy to understand, implement, and sustain. Becki has a passion for operational excellence and continuous improvement, which ultimately contributes to the health and benefit of the patients Medtronic serves.
Bassil Akra
Chief Executive Officer
AKRA Team
Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a globally acting consultancy company from Germany. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has vast experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standards. He spent the last years of his career at TÜV SÜD training and educating various stakeholders on EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving relevant designation ensuring continuity of the healthcare system in the interest of patient populations.