510k PRE-AUDIT. (UNDER CONSTRUCTION)



510k Pre-Audit Rationale.

The 510k Pre-Audit Years later the same problem became apparent to the medical regulators, and cGMP appeared. The inspection and assessment of quality became extremely important, and assessing your suppliers became mandatory. Documents like IQ,- OQ, - DQ, - PQ,- VRA,- VP, - URS, were born.

Just completed a 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 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.



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510k Pre-Audit Scope.

A 510k 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

510k Medical Device by Definition.

A medical device device is:

  • 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 and 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 the products they regulate.

510k PRE-AUDIT




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