How to write superb Medical Device Qualification Protocols

Introduction to FDA Medical Device Protocols.

Understanding How to write superb Medical Device Qualification Protocols using our templates can save the end user 50% to 75% of the normal authoring time. This use of interactive compliant documentation greatly simplifies the arduous task of producing all the Good Manufacturing Practice (GMP) compliant documentation which GMP compliance mandates.

Quality System Regulations for 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.

How to write superb Medical Device Qualification Protocols - introduction

It is essential that all equipment including software destined for use with devices are subjected to early testing that will rigorous detect critical bugs and security vulnerabilities. This is acceptable best practice for enhancing reliability while reducing off the shelf (OTS) software device qualification 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 " used as components in devices, to software that is itself a 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 of device validation including software development - everything from requirements and design reviews to software maintenance and retirement.  Any Device falling into Class IM, Class IS, IIa, IIb or III of the FDA Medical Device Templates  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 device validation by a Notified Body.


Verification & Validation.

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

Functional Testing Methodologies.

The simple view that each 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.

Understanding how to write superb Medical Device Qualification Protocols is a realistic and effective strategy requiring 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 device qualification 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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Medical Device Package Issue-3 10003000  $838.00

The DVP contains all the regulatory mandated documents. The hyperlinks and cross references between them make the package; not only unique, but also highly cost effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are presented formally. All the documents are written in MS word, to facilitate simple editing of text, layout, tables and schematics. 



Matrix + DMR + DHF + DHR


Medical Device URS Issue-3  10003006  $115.00

The URS is produced once the product is established. With the product concept documented – then the design / recipe can be further analysed. From these investigations the requirements for facilities, utilities, maintenance, calibration, operator skills, software, documented specifications and engineering drawings can all be extracted and provisioned for.


Medical Device DQ Issue-3 10003015 $115.00

With a company approved VP and URS produced; vendors can be invited to submit submissions. These submissions will be challenged by the execution of a DQ; which will or will not certify that the vendor’s submission; if proceeded with, will fully satisfy all the requirements listed in the URS.


Medical Device IQ Issue-3 10003020 $ 115.00

The Installation Qualification (IQ) section includes test scripts that when executed shall verify that each testable requirement applicable to installation is fully complied with. The SOP used to generate this IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol.


Medical Device OQ Issue-3  10003025  $115.00

The Operational Qualification (OQ) section shall include test scripts that when executed shall verify that each testable requirement applicable to Operation is fully complied with. You will find the step by step attached SOP delightfully simple and straightforward to use, as it takes you through the process of customization your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific Operational Qualification Protocol.


Medical Device  PQ Issue-3 10003030 $ 115.00

The Performance Qualification (PQ) section shall include test scripts that when executed shall verify that each testable requirement applicable to performance is fully complied with. The Process Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances.