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Medical device audits: what, when, how and who

WebIf a serious public health risk is identified during this inspection, the inspection may become a “for cause” inspection. Compliance Follow-Up Inspections. This type of inspection …

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URL: https://www.cognidox.com/blog/types-of-medical-device-audit

What are the 5 phases of medical device development

WebPhase 1: Initial ideation and risk analysis. This first phase of medical device development includes initial ideation followed by the opportunity and risk analysis that will determine …

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GXP compliance: everything you need to know

WebAnd their failure could represent a substantial risk to human health. Think of a strip of pills or a complex software-controlled medical device. Although batch testing is an important …

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MD, IVD, AIMD or SaMD

WebFrom the Latin meaning “within the glass”, in vitro diagnostic devices refer to tests used on biological samples outside the body, to determine state of health. The EU IVDR is the …

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What is post-market surveillance for medical devices

WebA post-market surveillance plan, addresses the collection and utilisation of information such as user feedback, trend reports, clinical follow-up data, and more. This …

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The 5 Pillars of GMP in the Pharmaceutical Sector

WebOverall, they must have repeatable methods for research, development, processing, manufacture and packaging, testing, sampling, status control, stability testing and record …

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9 ways QMS software helps you maintain & demonstrate GxP

Web9 ways the right eQMS software can help you maintain GxP compliance. 1. A good digital eQMS gives you the tools to define and document your SOPs in ways that make them …

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Why not just use Google Drive for your medical device QMS

WebA medical device QMS must protect your data and information from loss, misuse or accidental deletion throughout their lifecycle. A digital Quality Management System …

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Process verification vs process validation for medical devices

WebIn other words, verification is about checking against engineering specifications, while validation is about checking against user needs. The FDA Quality System Regulation …

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Life after Covid-19 for the IVD (in vitro diagnostics) industry

WebIVD innovation put patients in control. A new generation of IVDs are making diagnoses faster, more accessible and cost effective. And putting more data in the hands of patients …

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Medical Device Technical File Requirements

WebThe medical device technical file (now known simply as the medical device file) is a term used in ISO 13485:2016. It refers to the documents required by auditors …

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What is effective CAPA management

WebIt is part of a shift by regulators around the world from a paradigm of ‘inspect and correct’, to creating a culture of learning from errors and developing best practices through a …

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MDSAP 101: An Introduction to the Medical Device Single Audit …

WebThe audit is a three-phase audit process designed to ensure medical device manufacturers meet stringent quality standards. The process begins with an Initial Audit, divided into …

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Good Distribution Practices (GDP) In the Pharmaceutical Industry

WebIn the US, the world's biggest pharmaceutical market, the FDA enforce GDP (Good Distribution Practices), which are codified in the Current Good Manufacturing Practices …

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Implementing Medical Device Design Controls for ISO 13485

WebImplementing Medical Device Design Controls for ISO 13485 and FDA 21 CFR 820. 30 years ago the FDA introduced robust new requirements for medical device design control …

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The FDA submission process: 510K vs PMA. What’s the

Web510 (k) clearance is authorisation from the FDA to market a medium-risk medical device, while PMA (premarket approval) is required for more high-risk and novel products. PMA …

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What is 21 CFR Part 11

Web7 critical requirements for 21 CFR Part 11. 1. Data integrity. Part 11 requires that you have the digital process and controls in place to ensure the “authenticity, integrity, and, when …

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IQ, OQ, PQ: what's needed for equipment validation in life sciences

WebThe IQ, OQ, and PQ process for equipment is central to the smooth functioning of your operations and the delivery of end products that are safe and efficacious. Equipment …

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Visualising Risk-Based Thinking in a Quality Management System

WebThe concept of “risk” in the context of ISO 9001:2015 relates to the uncertainty in achieving these objectives”. Risk-based thinking, therefore, requires companies to constantly …

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What’s the Cost of Quality

WebCoPQ is the total sum of associated costs which are incurred due to the failure or absence of the standard operating procedures (SOPs) that are supposed to maintain quality. For …

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7 Quality Management Principles of ISO 9001:2015 and how to

WebUsing a graphical Quality Management system can help you embed the 7 Quality Management Principles into your organisational thinking. Here’s how: 1. Customer …

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A short guide to non-conformance reports; what, why and how

Web2. Fill out you non-conformance report (NCR) A non-conformance report should be raised that can: Capture the details of the identified non-conformance, such as the day, date, …

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