Getting design controls right is absolutely essential for medical device companies

Design Controls are absolutely essential for ensuring the safe and effective production of medical devices. The FDA too considers design Controls a critical process. Yet, design controls are among the most frequently cited areas for 483 and Warning Letter observations from the FDA. Although intrinsic quality, safety, and effectiveness of a device are known to […]

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 […]

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 […]

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made: Managing risks Validation of processes Establishing product/process specifications to QC to such specifications Monitoring compliance to such specifications Lack of proper and thorough grasp of and correct implementation of […]

New Way of Exploring Economic Environment

Lineament analysis in geological exploration The existence of efficient and cost-effective methods that help to identify prospective targets that are related to or are influenced by tectonic structures is not common knowledge among professionals in the field of geological exploration. The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of […]

Developing Documents and Records to meet the Requirement of ISO 17025

The major challenge for most laboratories is having to develop and implement a functional Quality Management System (QMS) that not only complies with the management and technical requirements of the ISO/IEC 17025:2005 standard, but also meets the laboratory’s needs. This is why QMS is considered the soul of the ISO/IEC 17025:2005 standard. A highly meaningful […]

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 […]

Get your HIPAA compliance right in six simple steps

The most important element that Covered Entities and Business Associates must keep in mind while carrying out HIPAA audits is best summarized in the words of Jocelyn Samuels, the top Federal official in charge of HIPAA enforcement. To quote her own words, Covered Entities and Business Associates must ensure compliance through “… a comprehensive and […]

Online compliance training

Compliance training is a vast area of continuing professional education. Professionals in any industry that requires compliance with set standards –this could mean almost any industry or profession –require compliance trainings. Compliance training is required in all these areas, and professional organizations offer these with the help of experts in the field. Online compliance training […]