Ways of conducting a hassle-free internal and supplier audit for medical devices

Carrying out efficient and effective internal and supplier audits that meet all the requirements of external auditors is a must for medical device manufacturers. These audits should not only serve this purpose; they should also add value to the medical device organization. Part of both ISO 13485 and QMS Internal audits are required as part […]

Preparing for an ISO 13485 audit

Being the current standard for medical devices; the ISO 13485 prescribes a set of standards that are to be implemented by manufacturers of medical devices. The aim of ISO 13485 is to ensure that medical devices meet the prescribed quality standards. This standard was conceived with the intention of making medical device manufacturers understand ways […]

The ISO 13485:2003 Standard has quality management systems at its heart

The ISO 13485:2003 Standard has quality management systems at its heart. The ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices. Its requirements ISO 13485:2003 specifically relate to organizations that are in the business of medical devices, no matter what its size or type. At its core, ISO 13485:2003 is […]

Design History File content

Design History File content The design history file (DHF) is a very important document for a medical device, because it is what may be called the route map for the product’s design. It is proof that the device followed the right method on the way to arriving as the final product. What is DHF? It […]

ISO 13485 vs. ISO 9001

ISO 13485 vs. ISO 9001 One of the most commonly countered questions in the medical device industry is: ISO 13485 vs. ISO 9001. They are often confused for each other. But they are never the same, although they have many common requirements. ISO 13485 is part of ISO 9001 family of regulations When understanding ISO […]

ISO 13485 internal audit

ISO 13485 internal audit So, you are in the medical devices industry, and one of the first items you would come across in your profession is having to deal with an ISO 13485 audit. What is the ISO 13485, and what does it take to audit it? Understanding the ISO 13485 First things first. Let […]

ISO 13485 Gap Analysis

ISO 13485 Gap Analysis Gap analysis is an important aspect of the ISO 13485 audit. The ISO 13485 standard lists out requirements for a wide-ranging management system for the manufacture and design of medical devices. When a medical device organization performs a gap analysis, it is analyzing the gaps that exist in its QMS vis-à-vis […]

Aspects to look out for in your ISO 13485 Quality Manual

Aspects to look out for in your ISO 13485 Quality Manual Each and every organization that implements ISO 13485, an important ISO standard, has to have a Quality Manualin place. The ISO 13485 sets out requirements for a complete management system for organizations that are in the business of designing and manufacturing of medical devices. […]

The ISO 13485 -what is it?

The ISO 13485  For anyone in the medical devices industry; the real buzzword perhaps is ISO 13485:2003. What is it? How does it matter to the industry? What are its exceptions? The medical device industry, given its enormous impact on human health and welfare; is highly regulated all over the world. In the leading blocks, […]

Pain is very subjective and individual

Description: Pain management is deeply emotional and spiritual, making it difficult to promulgate laws for its management  Are laws necessary for pain management? Pain management and existing laws have never been good friends. There are regulations and laws at state and federal levels that have attempted to regulate, organize and standardize pain management systems; however, […]