Quality audits for the medical device industry

Quality management systems of medical devices have to go through well-defined quality audits. Medical device companies need to implement these in order to show compliance with quality. ISO 13485 is the quality management standard for medical devices. Based on the process approach of this document and that of 21 CFR part 820 the Global Harmonization […]

HIPAA Security Rule Principles

Though short in length,HIPAA Security Rule principles are well defined in some areas, but vague in some others, making implementation of these areas difficult. HIPAA Security Rules are an offshoot of the Privacy Rule. While Privacy Rule concerns itself with Protected Health Information (PHI) in general, the HIPAA Security Rule (SR) concerns itself specifically with […]

Unravelling the DHF, Technical File and Design Dossier

Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD. The Design History File The […]

Validation of Pharmaceutical Water Systems

Thorough and proper validation of pharmaceutical water systems is highly essential for ensuring that the pharmaceutical unit uses the right quality of water. This is very important, because water is not only the source of life for humans; it enjoys the same importance in pharmaceuticals. A very important reason for which validation of pharmaceutical water […]

What Would Happen to Health Spending Under ACA?

The growth in health care spending is expected to have slowed in 2016 and to remain slow in 2017, due to slower enrollment in government-sponsored Medicaid and a reduction in spending on prescription drugs, according to a report released Wednesday by actuaries from the Centers for Medicare and Medicaid Services. The report, published in the […]

How to build a complete Safety, Health & Environment Management System through Standards & Practices 2017

    Course “How to build a complete Safety, Health & Environment Management System through Standards & Practices” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. Overview: A management system, by definition, is a process by which a function or functions are carried out in an organization […]

Article on FDA 21 CFR Part 11 Compliance

FDA-regulated industries electronic signatures and other records are considered authentic. From 2007, a strong body of opinion has emerged challenging the stringency of these requirements, but nothing major has been diluted from these. The regulations under FDA 21 CFR Part 11 Compliance set out criteria that the Food and Drug Agency (FDA) considers in order […]

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 […]

Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance. What makes preparing premarket submissions that win regulatory approval […]

Applied statistics for scientists and engineers

Applied statistics for scientists and engineers is necessary for a number of reasons. 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods for these functions: o  Setting validation criteria and specifications o  Performing Measurement Systems Analysis (MSA) o  Conducting stability analysis o  Using Design of Experiment (DOE) for process […]