The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System [...]
The AAMI/BSI International Conference on Medical Device Standards and Regulations is coming to Europe! During this event, government and industry leaders from Europe and the US will explore developments in international standards and regulations that are key to global market access and regulatory compliance. For more info: http://www.aami.org/events/eventdetail.aspx?ItemNumber=5759
The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System [...]
This 2 day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system. Some primary topics include: the purpose of a CAPA system and how it is integrated throughout a Quality Management System; appropriate data sources and how to coordinate, analyze and manage them; methods for verifying and / or [...]
This intensive 2½ day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. This course offers FDA and industry the unique opportunity to participate in a shared learning experience. Examples of design control tools, templates, and practices, in use by AAMI member companies, stimulate discussion and [...]
This annual celebration is designed to promote the awareness of—and appreciation for—the critical work of biomedical equipment technicians (BMETs), clinical engineers, and other members of the healthcare technology management (HTM) field. For more info: http://www.aami.org/events/content.aspx?itemnumber=1236&navItemNumber=566
The webinar will provide a working knowledge of Test Method Validation (TMV), also known as Measurement System Analysis (MSA) and Gauge R&R (GR&R). Concepts covered are also applicable to Analytical Procedures. The names are not important, the application of this very valuable statistical methodology is essential for a quality system. The key question is: How [...]
National Small Business Week is being held from April 29-May 5 and is an annual event hosted by the U.S. Small Business Administration to recognize the nation’s top small businesses, entrepreneurs, small business advocates and champions. Every day they’re working to grow small businesses, create 21st century jobs, drive innovation, and increase America’s global competitiveness. [...]
The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s CDER and CDRH. The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. Our primary audience is that of small manufacturers of drug and/or [...]
When contemplating the difference between human factors (HF) validation and design validation, the Venn Diagram is your friend. The two types of validation efforts almost always overlap. However, HF validation is not necessarily a simple subset of overall design validation. This webinar will clarify these points and guide medical device developers toward an efficient and [...]