Health Buzz: The 10 Best States for Health Care

  If you want to get the best health care, you might be better off living in one of these states, according to a new ranking. Hawaii, Iowa and Minnesota topped WalletHub’s new ranking of the best states for health care. The ranking took into account 35 metrics in the categories of cost, accessibility and health […]

Seminar Calendar of Upcoming Courses – June to July – 2017

seminars are a wonderful opportunity for professionals in the regulatory compliance

Article on Effective techniques for extracting information from geochemical data are largely ignored by the industry

In the area of geochemical data analysis techniques and obtaining geochemical extracting information; most mining specialists strongly recommend an approach that goes beyond merely asking the laboratory for geochemical extracting information of a gold test by sampling every meter of the drill core of a trench and using multielement analysis. There, however, exist other methods […]

Ensuring that analytical data in laboratories are accurate, reliable and consistent

Ensuring that analytical data are reliable, consistent and accurate is the fundamental reason for which analytical methods and procedures need to be validated. The employment of proper scientific methods and procedures by laboratories and validating them ensures the reliability, consistency and accuracy of the analytical data. The purpose of doing so is to corroborate the […]

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD)

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical […]

Payroll laws are varied, hence need to be applied thoroughly and thoughtfully

  Payroll laws set out the rules for which payroll regulations are to be enforced. Payroll laws and regulations have been enacted since it is through the payroll that employees not only get paid; it is also the same source for taxation and other deductions. Every organization that has a payroll system has to adhere […]

Standard Operating Procedures are crucial documents in the regulatory industry

  Standard Operating Procedures (SOPs) are very important documents that can make or break an organization in the regulatory industry. In simple terms, a Standard Operating Procedure, as suggested in its nomenclature, is a description of a specific operational procedure in which all the activities necessary to complete tasks that conform to established best practices, […]

Risk Management Seminar for Applying ISO14971 and IEC62304

  Course “Applying ISO14971 and IEC62304 – A guide to practical Risk Management” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. Overview: Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot […]

Management for Medical Device Industry

  A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of the global market, and is expected to grow by over 20 percent […]

Management systems should be expansive and versatile

Management systems should be expansive and versatile, as having such a system makes sense for organizations. A management system is a mechanism that helps streamline an organization’s day to day functioning without hassles. It should put the organization on the path it chooses to take by putting in place a set of documents that is […]