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Medical Device Validation Template


Medical Device Validation Rationale.

The Medical Device Validation Template must define & verify; boundaries, responsibilities, executables & requirements for device validation to be successful

The verification that your suppliers are fully conversant and compliant with all the regulatory obligatory requirements has become a rather burdensome load for some companies and an unacceptable load for others. However: the growing expectation is that these subcontractors will; step by step,  increase their cGMP compliance level.

This continuing upsurge in subcontractor cGMP compliance must result in the industry becoming familiar with the authoring, reviewing and approval of the full suite of cGMP document.  Documents such as: IQ,OQ, DQ, PQ,VRA,VP, URS, were born.

Just completed a medical device validation template supplier assessment; how important was your documentation? How important was your justification for your decision? Have you been biased in your judgement? Were your priorities right? How did you get it so wrong? These are questions that are in the minds of all persons affected by an adverse audit outcome. To make certain that you are going to be ‘squeaky clean’, every question, and every answer and observation, needs to be clearly documented. The company priorities must be understood and integrated into the weighting of the 510k Pre-Audit documents. If you are auditing on behalf of a client, they have a right to review your assessment documents, and you are required to be impartial and accurate in your findings.

Assurance services involve the internal auditor's objective assessment of evidence to provide an independent opinion or conclusions regarding an entity, operation, function, process, system, or medical device validation template or other subject matter. The nature and scope of the assurance engagement are determined by the internal auditor. There are generally three parties involved in assurance services: (1) the person or group directly involved with the entity, operation, function, process, system, or other subject matter - the process owner, (2) the person or group making the assessment - the internal auditor, and (3) the person or group using the assessment - the user.


Medical Device Validation Template Te Scope.

A Medical Device Validation Template; pre-audit quality assessment questionnaire must cover the under listed topics but it must use a method of weighting the topics in order that the clients really critical topics have a more significant impact on the vendor’s assessment.

  • General.
  • Organization & Personnel.
  • Facilities
  • Equipment.
  • System Integration.
  • Development Plan.
  • Test Plan.
  • Configuration Management.
  • Customer Support.
  • Product Security.
  • Change Control.
  • Quality Systems.
  • Document Control.
  • Program Documentation.
  • Documentation Management

Medical Device Validation Template by Definition.

A medical device defined

An apparatus, instrument, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.

  • Listed in the official National Formulary, or the United States Pharmacopoeia.
  • Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.
  • Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

Medical Devices Validation Templates & Other Regulated Products.

This definition provides a clear distinction between a medical device and other FDA regulated products such as drugs.

  1. If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug.
  2. Human drugs are regulated by FDA’s Center for Drug Evaluation and Research (CDER).
  3. Biological products which include blood and blood products, and blood banking equipment are regulated by FDA’s Center for Biologics
  4. Evaluation and Research (CBER).FDA’s Center for Veterinary Medicine (CVM) regulates products used with animals.
  5. If your product is not a medical device but regulated by another Center in the FDA, each component of the FDA has an office to assist with questions about medical device validation template products they regulate.

MEDICAL DEVICE VALIDATION TEMPLATE



Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation 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 and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; i.e, The User Requirement Specification template. 



User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation 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. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.