GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a […]

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 […]

Comprehensive risk management is a must for medical device software

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons: Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products […]

Tools and Methodologies to Predict and Improve Product Reliability

Improving product reliability may be the primary objective of reliability analysis; yet, there are many possible reasons for collecting and analyzing reliability data. There are many examples of collecting and analyzing reliability data. This could be done to assess product reliability in the field. It could be to predict product warranty costs. It could be […]

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 […]

Verification vs validation is a key understanding for regulatory professionals

For regulatory professionals, aspects of verification and validation, such as how to get verification and validation right, and an understanding of the ways in which verification and validation diverge from each other and converge, make up very important learning. The key point is that verification and validation should be risk based and be built keeping […]

Implementing the 510 (K) correctly in compliance with the latest proposed FDA changes

A 510(K) is a premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective, meaning that which is substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). There are three types of Premarket Notification 510(K)’s that may be submitted […]

Finessing the ways of using lineament analysis in geological exploration

Geological exploration has many benefits for mankind. Yet, there are a few limitations with the current set of methods being used by geologists. The full extent of technologies is yet to be harnessed. The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process if the […]

ISO 9001’s Process Approach to Quality Management

ISO 9001 came into being exclusively as a means of incorporating a process approach to quality management systems. Both ISO 9000 and ISO 9004 underwent an amendment in 2000 to put this approach into place. It is all about process Where this approach differs from the previous standard is that it improves upon it by […]