The Cutting Edge of Medical Technology Content, Community & Collaboration
Compliance for medical devices is a very broad and vast topic. When one talks of compliance for medical devices, one needs to keep in mind the various regulations that the FDA has put in place for manufacturers of medical devices to comply with. The FDA requires strict compliance with its laws and requirements because it is charged with the task of ensuring the quality requirements of medical devices, which are a means to ensuring that the medical devices are safe and effective.
The FDA has undertaken the task of ensuring that medical devices, along with select nonmedical devices adhere to regulations pertaining to manufacturing; repackaging, relabeling and/or importing medical devices sold in the US comply with its requirements through its Center for Devices and Radiological Health (CDRH). The requirements for compliance for Class I, II and III medical devices, such as the registration of the establishment, listing of the medical device, 510 (k), premarket approval investigational device exemption (IDE), Quality Systems, GMP, device labeling and device reporting are set out in the various sections of 21 CFR Part 807.
A GlobalCompliancePanel seminar which will cover all the important areas of compliance for medical devices
A seminar that is being organized by GlobalCompliancePanel, a highly reputable provider of professional trainings for the areas of regulatory compliance, will be delving into the details of all that is required for compliance for medical devices. A boot camp of sorts, this seminar, which will cover all the important areas of compliance for medical devices, will have Susanne Manz, Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc. as the speaker.
To enroll for this very valuable seminar, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~produc... . This seminar on compliance for medical devices has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
A boot camp to ensure compliance for medical devices
Susanne will help participants from the medical devices industry get a thorough idea of what it takes to ensure compliance for medical devices. She will show ways by which to improve the quality and compliance of medical devices, while at the same time, optimizing costs. This boot camp is a means to building a sound Quality System with which to ensure compliance for medical devices.
An important piece of learning that Susanne will bring into this seminar is how to understand regulatory requirements and translate them into an effective and efficient Quality System. The ways of planning, structuring, and implementing a Quality System that addresses the specific business needs of the participants will be addressed at this seminar.
Means to address issues within a medical device company’s Quality System
In discussing how to create a quality strategy and plans; Susanne will explain some of the methods that need to be put in place for identifying, prioritizing and analyzing risks. She will help explore the capabilities that every medical device company needs to have if it has to ensure quality products and a compliant Quality System.
In this seminar on compliance for medical devices, Susanne will also take up important related items such as continuous improvement, Six Sigma, and Corrective and Preventive Action (CAPA) to address issues within a medical device company’s Quality System. The ways of effectively communicating and escalating risk, as well as monitoring performance and progress, as well as how to kick start the Quality System into avoiding common problems such as MDRs, recalls, 483s, and Warning Letters, will all be covered in this seminar on compliance for medical devices.
Susanne will cover the following areas at this seminar:
o Quality System Expectations
o Quality System Structure
o Strategy and Planning
o Risk management in your quality system
o Case for Quality
o Inspection preparedness and management
o Monitoring and metrics
o Creating a quality strategy and plans.