This interactive workshop brings together senior regulatory leaders from the medical device industry with extensive experience in global regulatory strategy to share best practices and discuss how to evaluate the regulatory and market potential landscape, the coordination of internal resources in the context of MDR/IVDR, Brexit, tariffs, and other factors, business strategies, and other critical issues.
The growing number of medtech mergers & acquisitions poses unique due diligence challenges. Regulatory, quality and compliance experts must validate statements and assumptions, evaluate findings, and map strategies for integration. This workshop will help attendees navigate the process.
Among the many changes resulting from EU MDR are new requirements for labeling, instructions for use, UDI, risk assessment for hazardous substances, and transparency of product data through the Eudamed database. Establishing the systems and protocols for remediation of current products and compliance of new ones will be a complex, costly, and time-consuming process.
The 7th annual MedTech Intelligence Recalls conference, developed in close collaboration with FDA and industry leaders, discusses emerging issues in risk and health hazard determination and the practical conduct of recalls and other field actions.
This highly interactive program is intended to help manufacturers and hospitals – independently and in collaboration – better understand steps they can take to improve medical device cybersecurity throughout the product life cycle. This event takes place in Cambridge, MA.
The EU IVDR establishes a new risk-based classification system, stricter postmarket surveillance, upgraded dossiers for all products and notified body review of previously self-declared products, greater clinical evidence requirements, and emphasis on transparency & traceability, including reporting risk, clinical, safety, and performance data to a publicly available database. It will require massive investments of time and money, and changes in organizational structure. Plan now!
The EU MDR requires a novel level of oversight throughout the entire supply chain – supplier, manufacturer, authorized representative, importer, and distributor. Economic operators incur added responsibilities and are subject to greatly increased scrutiny. This new flow of responsibility for monitoring compliance necessitates changes in contractual agreements and organizational structures.
EU MDR requires more premarket & postmarket device safety and performance data; rigorous clinical information and active collection and analysis of postmarket experiences,for legacy devices & new products. New processes & governance will be needed to support this assessment and ongoing file updates.
High-level approach to business strategy & organizational challenges of evaluating a portfolio of legacy & pipeline products to determine the impact of EU MDR, perform a gap analysis, calculate the profit and cost of remediation, establish a timed & stratified approach, and to modify or create internal structures needed to bring current products into compliance.
Not a 101 course, this workshop brings together leading industry CAPA process owners to discuss approaches to the most difficult problems in CAPA and root cause analysis.