Medical Devices
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Medical Device Reporting – How to establish and maintain adequate procedures
Description: This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting. Device manufacturers are required to establish and maintain medical device reporting procedures pursuant... -
Implementing an Internal Audit Program of QMA, Persisting to ISO 13485 and 21 CFR Part 820
Description: This webinar is intended to help you adequately develop an internal audit program of a firm’s quality management system (QMS) as required by ISO 13485 or 21 CFR Part 820. 21 CFR 820.22 states “Each manufacturer shall establish... -
The FDA 510(k): Q-Submission, Preparation and Submission
Description: This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. This webinar is intended to discuss what and how to... -
Unique Device Identification (UDI) Final Rules Overview
Description: This webinar is intended to help you get familiar with the Unique Device Identification (UDI) final rules, finally issued on September 24, 2013. This webinar is further intended to help you effectively implement a unique device identification (UDI)... -
510(k) for IVDs
Description: This webinar is intended to demonstrate 510(k) contents and format including 510(k) processesin accordance with FDA’s eCopy and RTA policy, helping you streamline your 510(k) preparation, submission and successful clearance for IVDs, saving days, weeks or months of... -
Good Practices for FDA 510(k): Content and Format
Description: This webinar is intended to demonstrate 510(k) contents and format including 510(k) processes in accordance with FDA’s eCopy and RTA policy so that your time, energy and financial resources can be effectively used to accelerate your 510(k) preparation,... -
Extending Your Quality System from Medical Devices to Manufacturing of Combination Products, Your Unique Challenges and How to Overcome them
Description: This webinar is intended to demonstrate 510(k) contents and format including 510(k) processes in accordance with FDA’s eCopy and RTA policy so that your time, energy and financial resources can be effectively used to accelerate your 510(k) preparation,... -
FDA proposed changes to ISO 13485: 2015 and Medical Devices Quality Management Systems
Description: Differences in regulatory requirements between Medical Devices and Pharmaceutical products poses unique challenges to companies that want to manufacture devices that contain drugs and biological products (aka Combination Devices). Large and small medical device companies who want to... -
Key Areas of Focus for Supplier Management in the Medical Device Industry
Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485 have specific product verification and validation requirements that must be fulfilled in... -
FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices
Description: This course will be immensely helpful to Supplier Auditors and Supplier quality engineers who would like a deeper understanding of the fast changing medical device regulations that are pertinent to bringing in a new supplier and maintaining them... -
Corrective and Preventive Action (CAPA) utilizing the Principles of Lean Documents and Lean Configuration
Description: Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design... -
Medical Devices and Pharmaceutical Quality Management System – Applying the Principles of Lean Documents and Lean Configuration
Description: All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21... -
Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration
Description: The Theory of Lean Documents is the product of applying lean principles to the Quality Management System (QMS) documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems, many traditional document... -
Design Inputs – Design Outputs Traceability Matrix – Principles of Lean Documents and Lean Configuration
Description: The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems,... -
21 CFR Part 820 – Quality System Regulation – Applying Principles of Lean Documents and Lean Configuration
Description: Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design... -
FDA’s New UDI Labeling Requirements
Description: All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21...
