Telehealth

This publication is a document bundle containing the following ROFRI MED documents:

●A Strategic Road Map - GUIDANCE;
●Process Validation SOP - TEMPLATE;
●Validation Master Plan - TEMPLATE.


A Strategic Road Map – GUIDANCE

The e-book - A Strategic Road Map, is the first in a series under the title Technical Series on Process Validation Principles and Practices.

It introduces medical device manufacturing process validation road maps by first visiting the issues that face many medical device manufacturers today in the area of process validation. This is followed by a step-by-step illustration of the process validation journey that runs from the process design stage through manufacturing process qualification to continued process verification.


Process Validation SOP – TEMPLATE

The e-document is presented in the form of a standard operation procedure for validation of medical device manufacturing processes. It covers elements of process validation, determining the scope of process validation, protocol and report development and strategy for maintaining the validation state.

Also included are the use of historical data in process validation, application of process equivalency in process validation and process revalidation requirements.


Validation Master Plan – TEMPLATE

The e-document is presented in the form of a generic template for use in developing a validation master plan (VMP). VMPs assist in scheduling of project activities for process validation; help management understand what validation activities will require in respect to time, staffing, finances, etc.; enlighten the validation team on their tasks and responsibilities; and specify for the auditors the validation approach employed and the organization of the validation activities.

The e-document is purposefully concise to enable fast reference by engineers and other professionals involved in validation activities for medical devices. It uses specific and detailed illustrations to facilitate grasping of the concepts and populating of the VMPs for processes, production lines or value streams.

Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing.

Filled with examples drawn from the author’s experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard into feasible activities and tasks. The book provides a full analysis of each clause and sub clause through quality perspectives: the implications on an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentations and records.

The book is organized like the standard itself — the table of contents is identical to the ISO 13485 Standard’s table of contents — making it user friendly, familiar, and unintimidating. You can use the book as a consulting session — read it, explore it ,extract ideas — and draw on the information and knowledge that suits you and your organization, and then apply it effectively to your quality management system and processes.

Based on a workshop of the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. This was the third workshop, held in April 2000. Softcover.

The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the MDDR Users Group on LinkedIn.

This book is presented in the form of a standard operation procedure for validation of medical device manufacturing processes. The book covers installation qualification (IQ), operation qualification (OQ), process performance qualification (process PQ), product performance qualification (product PQ), test method validation (TMV) and equipment software validation. Also included are the use of historical data in process validation, application of process equivalency in process validation and process revalidation requirements.

Written for medical device designers, biomedical engineering students, physician entrepreneurs, and medical device entrepreneurs, this reference explains the basics on how to prototype and develop a medical device. It discusses the basics of plastics, adhesives, medical needles, and rapid prototyping as well as tips and tools to save time and money. This updated and expanded second edition includes practical advice and interviews from key opinion leaders and pioneers in the field. Extensive references at the end of each chapter enhance additional study.

Here s the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.

Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your software s safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.

From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, and in compliance with regulations. Additionally, an entire part of the book is devoted to the validation of software that automates any part of a manufacturer s quality system and is regulated by 21 CFR 820.70(i).

DVD Included! Contains a collection of FDA regulations and guidance documents related to software in the medical device industry, valuable sample forms and templates, and supplemental figures that support key topics covered in the book.

Design and Development of Medical Electronic Instrumentation fills a gap in the existing medical electronic devices literature by providing background and examples of how medical instrumentation is actually designed and tested. The book includes practical examples and projects, including working schematics, ranging in difficulty from simple biopotential amplifiers to computer-controlled defibrillators. Covering every stage of the development process, the book provides complete coverage of the practical aspects of amplifying, processing, simulating and evoking biopotentials. In addition, two chapters address the issue of safety in the development of electronic medical devices, and providing valuable insider advice.

Design Controls for the Medical Device Industry provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations. It also offers product development models for the production of safe, durable, and cost-efficient medical devices and systems. The book details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. It presents blueprints for the application, evaluation, and refinement of quality assurance and performance practices, from product launch through engineering and assembly.

The goal of this textbook is to provide undergraduate engineering students with an introduction to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining 8 chapters are medical device laboratory experiment chapters.

Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach enables students to quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI).

 

Key Features:

The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areasThree significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chaptersExercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literatureEight laboratory experiments are detailed that provide hands-on reinforcement of device concepts