Why Should You Attend:
MDR Reporting is a critical element of any Medical Device Manufacturers Quality Management System. It requires employee engagement, understanding of applicable Code of Federal Regulations and understanding of the interplay between complaint handling.
Attendees will learn the key elements of a winning reporting system and how they relate to other functions (ex: Complaint handling management, Screening & Evaluation for reportability, employee training and expectations). The presentation will cover best practices for reporting and building a winning complaint handling and MDR team.
Areas Covered in the Webinar:
Who Will Benefit:
Kwame Ulmer is a MedTech executive with 15 years of experience in government and the private sector. Mr. Ulmer integrates his experience working as an operating company executive, evaluating over 1,000 technologies at FDA, advising early stage companies, and formal business education to deliver high-impact consulting services.
Mr. Ulmer previously served as Vice President, Regulatory Affairs & Quality Assurance at Implant Direct, a Danaher Corporation Operating Company. Mr. Ulmer, led all efforts to accelerate market access via shortened global registrations timelines, improved product quality via process optimization and led activities resulting in best-in-class department engagement scores.
Kwame has served in progressive leadership roles at the US Food and Drug Administration (FDA). He managed the two fold growth of a Division to 74 employees and has personally evaluated hundreds of cardiovascular, ophthalmic and dental technology applications.
Since 2011 FDA has required individual malfunction reports for devices, unless a reporting exemption or variance was granted for specific devices, or until the agency gave further notice on summary reporting criteria.
FDA launched a pilot initiative to explore criteria for quarterly summary reporting for low-risk Class I and Class II devices. Manufacturers must stay abreast of regulatory changes and lead key personnel to stay current in training and compliance.
Regulations: FDA 21 CFR 820.198 , ISO 13485:2016 section 8.2.2.
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