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7.3.7 Design and development validation – Objectives
Did you design the right Medical Device? This is the main question that design and development validation needs to answer. design validation refers to the sum of all efforts necessary to ensure that the design actually meets the requirements: user needs, intended use, performance safety, and regulatory requirements. With design verification, we ensured that »
ISO 13485: Risk Management integrated in the Design and the Development
In clause 7.3.2—Design and development planning, the organization is required to maintain a plan to control the design and development of the medical device. This plan will include process elements like a systematic process plan for the design and development of the product, defined method to control the progress of the design and evelopment, »
ISO 13485:2016 Standard- Table of contents
The book is organized like the standard itself, the table of contents is identical to the ISO 13485 Standards table of contents making it user friendly, familiar, and unintimidating. Each chapter contains the information, explanations, interpretations and examples regarding the requirements stated in the parallel standard clause. The book is 900 pages long. Are »
ISO 13485:2016 Standard – 7.1 – Planning and documenting risk management activities
The organization is required to define, plan, establish, document, and maintain one or more processes for risk management activities that will cover the entire realization processes of the medical device and refer to all phases of the life-cycle of the medical device. The definition of the ISO 13485 Standard for risk management is: a »
Practical FAQ about ISO 13485
What is the ISO 13485 Standard? The ISO 13485 Standard is an International Standard which specifies requirements for a quality management system to be be used by an organization involved in designing and/or producing medical devices. The standard refers to one or more stages of the life-cycle of the medical device. The standard can be »
Comparison Matrix FDA QSR 21CFR 820/ISO 13485:2016
Important notice regarding the matrix – it refers to the current FDA QSR 21CFR 820 and not to one to come. FDA-QSR-21CFR-820 ISO 13485 § 820.1 – Scope. 1 Scope 820.5 Quality System 4.1.1 Quality management system, General requirements 820.20(a) Quality Policy 5.3 Quality Policy 5.4.1 Quality Objectives 820.20(b) Organization 5.5.1 Responsibility and »
The challenges of Computer Systems Validation (CSV)
The Computer Systems Validation (CSV) is requested by the ISO 13485 in clause 7.5.6 – Validation of processes for production and service provision. The requirement: The organization shall document procedures for the validation of the application of computer software used in production and service provision. Such software applications shall be validated prior to initial use and, »