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. Registration will open soon.
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. Registration will open soon.
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 will take place in Cambridge, MA. Registration will open soon.
The new EU In Vitro Diagnostics Regulation will profoundly affect the IVD market in Europe. 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 novel emphasis on transparency and traceability, including reporting of risk, clinical, safety, and performance data to a publicly available database will require massive investments of time and money as well as significant changes in organizational structure. The transition period may seem long, but consultants and the dwindling number of notified bodies are already swamped with EU MDR implementation. Help will be hard to find. Planning should start now. Registration will open soon.
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. Registration will open soon.
The EU MDR requires significantly larger amounts and different types of both premarket and postmarket device safety and performance data. In addition to more rigorous clinical information and active collection and analysis of postmarket experiences – for legacy devices as well as new products – new processes and governance will be needed to support this assessment and ongoing file updates. Registration will open soon.
The new European medical device regulation imposes a broad array of stringent new requirements on medical device manufacturers. This program takes a high-level approach to the business strategy and organizational challenges of evaluating a company’s portfolio of legacy and pipeline products to determine the impact of the new regulation, perform a gap analysis, calculate the profit and cost of remediation, establish a timed and stratified approach, and to modify or create those internal structures needed to bring current products into compliance and to efficiently maintain compliance in the future. Registration will open soon.
CAPA is the most critical and challenging quality system requirement in terms of complex thinking and organizational processes. Not a CAPA 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.
Rules and procedures for import and export of medical devices are growing more so with new rules and with changes in international trade agreements. Customs and FDA have been requesting more information and conducting more inspections and examinations than before. Mistakes in procedures or documentation can lead to withheld or seized shipments and consequent financial lost to U.S. and foreign manufacturers, suppliers, and brokers. This one-day program with speakers from government, industry, and consulting firms will cover the laws and regulations, recent changes, procedures, best practices, and common mistakes. Registration will open soon.
Deficiencies in process validation and other aspects of production and process control earn more FDA enforcement actions than any other quality function except CAPA. This two-day workshop addresses key issues in process validation, including risk-based determination of processes to be validated, FDA and 13485:2016 requirements, key process validation elements and best practices, statistical and other tools, maintaining the validated state, and documentation.