MEDICAL DEVICE VALIDATION .


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Introduction to Medical Device Validation.

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Validation of medical devices is mandated within the; FDA 21 CFR part 820.  These form part of the Quality System Regulations established by the U.S. Food and Drug Administration (FDA) to direct Medical Device manufacturers and ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics and devices) are known as current good manufacturing practices (CGMPs).  Current good manufacturing practice requirements are set forth in this regulation, and are consistent with the requirements for quality systems contained in applicable international standards, like ISO 9001 and ISO 13485.  Quality System Regulations for medical device manufacturers do not regulate how a manufacturer must produce its product. Rather, the regulation defines the framework and elements that must be present in a quality system.

Medical Device Classifications.

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It is essential that all equipment including software destined for use with medical devices are subjected to early testing and review techniques that will rigorous detect critical bugs and security vulnerabilities. This is acceptable best practice for enhancing reliability while reducing off the shelf (OTS) software medical device validation costs. 

The FDA has issued guidance for proper validation of software in the form of the General Principles of Software Validation. The guidance applies to any "...software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer's quality system. 

The FDA's guidance covers all aspects medical device validation including software development - everything from requirements and design reviews to software maintenance and retirement. 

Any Medical Device falling into Class IM, Class IS, IIa, IIb or III of the Medical Device Directive (93/42/EEC), must encompass the following 2 basic elements, as part of a Compliance Strategy;  

·            A Technical File - covering all Safety and Performance issues, and

·            Either basic GMP or a Formal Quality System (eg: ISO 13485:2003 or ISO 9001:2000 or both) depending on your company's business objectives.

Class I Devices - Generally, require just Internal Control of Production and compilation of a Technical File. The Technical File then has to be held in case of a request by a Competent Authority. The final step is Self Certification and Registration with a Competent Authority.

Class IIa Devices - Require a Quality Management System to ISO 13485:2003 or ISO 9001:2000 or Annex V and compilation of a Technical File. The final step is an audit by a Notified Body.

Class IIb Devices - Require a Quality Management System to ISO 13485:2003 and compilation of a Technical File. The final step is an audit by a Notified Body.

Class III Devices - Being the highest risk devices, it is necessary to implement a Quality Management System to ISO 13485:2003 and compilation of a Design Dossier which is a more detailed Technical File. The final step is an audit of your medical device validation by a Notified Body.


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Verification & Validation.

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The regulators today expect medical device validation to perform to a high level. At the same time, the medical device business has become highly regulated. For medical device validation to perform in this environment, the production testing of medical device must have both compliant procedures and an excellent technical strategy.

The simple view that each medical device validation has a set of functional specifications and that each device produced must be tested to those specifications is both ineffective and inefficient. An exhaustive test for the complete specifications of an implantable cardioverter defibrillator (ICD), for example, would take significant energy from the device's battery and reduce its useful life. Exhaustive testing to functional specifications is best left to the design validation tests that are a required part of device certification.

A realistic and effective medical device validation test strategy requires several sets of test requirements based on component and manufacturing process specifications as well as critical functional specifications of the device. Test requirements describe and delineate setup conditions, stimuli and expected response parameters for individual experiments that constitute test steps. Test requirements are based on an understanding or model of real physical phenomenon. The model is never perfect, so measuring test coverage according to the test requirements is never perfect. Even a test that covers 100% of the requirements does not deliver a perfect product.

A set of medical device validation test requirements is needed because testing occurs repeatedly at different stages of manufacture, from component acceptance to final assembly. Each stage has a different set of specifications as well as different physical constraints on the test process.

Functional testing is necessary, and leaving all of it to final assembled devices drives up the rework cost. Implantable medical device validation are ordinarily hermetically sealed (welded titanium cans for ICDs), which makes repair difficult.

Limited access to the complex circuitry in a finished device makes functional testing an appropriate choice. At this stage in the manufacture, the number of defects has been greatly reduced by eliminating defective components and repairing defective interconnections found by previous testing. For reasons previously mentioned, the functional testing needs to be limited. The focus for device level functional testing shifts from diagnostic resolution to highest efficiency of coverage. That is, stimuli are set up which produce responses that involve major sections of the circuitry, and as much data is gathered from each response as possible.


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Computer Combined IQ-OQ-PQ (Issue 3) -- $159.00

This combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand-alone equipment. It is interactive, easy to use and suitable for all mixes of equipment with and without software.

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Computer User Requirements Specification (Issue 5.) -- $115.00

The document that sets the standard, and specifies your computer requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved.

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Computer Validation Master Plan (Issue 5.) -- $115.00

The Computer Validation Master Plan, is the starting point for validation, and hence the most important validation document. It improves validation efficiency greatly by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is an expected document with the FDA, and a mandated document with the EU.

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Computer Validation Package 1. (Issue1) -- $675.00

This computer validation is suitable for all major validation projects and contains the under-listed interactive documents. VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.

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Computer Validation Package 2. (Issue 3.) -- $580.00

The complete chain of regulatory required documentation; for the validation of a computer system, minus the VMP. This Validation Package contains one of each of these documents: VP, URS, DQ, VRA, IQ, OQ, PQ.

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Computer Vendor Audit (Issue 3.) -- $87.00

This Computer Vendor Audit document should be customised using the built in tools. The document can then be targeted to reflect your project priorities. The fifteen chapters all contain 10 questions, the total scored is then weighted to reflect your priorities. By assessing the importance of each of the chapter subjects in your project, the weighting is altered taking points from one and adding to others. This enables your assessment to be expressed simple and clearly as a percentage, allowing clear unambiguous comparisons to be presented for competing companies.

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CSV Design Qualification (Issue 3.) -- $89.00

The Standard Operating Procedure attached to this generic computer design qualification protocol, will chapter by chapter take you through the task of raising a fully detailed protocol. The main body is split into fourteen tables, each one probing the computer design requirements and standards for the individual requirement. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.

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CSV Installation Qualification (Issue 6.) -- $89.00

 Computer Installation Qualification (CIQ) is an important step in the overall validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements.

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CSV Operational Qualification (Issue 6.) -- $89.00

Operational Qualification (OQ) is an important step in the overall validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements, progressively and simply.

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CSV Validation Plan (Issue 3.) -- $89.00

This document follows Validation Online's standard method of using a fully detailed and interactive generic document and enabling to use the attached SOP to quickly convert this generic document into a first class company bespoke document. This CSV VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.

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Computer Performance Qualification (Issue 7.) -- $87.00

The Computer Performance Qualification is the culmination of the validation process. The protocol is used in conjunction with the system operating SOP, to verify that the system process is consistent and correct. The results of the testing must be recorder and reviewed with a view to ensuring that the deviancies (within permitted tolerances) that exist are random and not a trend that will lead to out of specification operation during production use.

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