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Medical device audits: what, when, how and who
WEBAudits will be conducted by UK Certifying Bodies, who will ensure compliance with the new regulations and issue UKCA markings. The deadline for new medical devices and IVDs (In Vitro Diagnostic Devices) to comply with this regulatory requirement is now July 2025. …
Actived: 9 days ago
URL: https://www.cognidox.com/blog/types-of-medical-device-audit
Medical Device Development Guide
WEBThe complete guide to medical device development. If you want to be a successful medical device developer, you need more than just a great idea for a product and skills to build it. You also need rigour and control. This page is a guide to designing and developing a …
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 two stages: Stage 1 focuses on reviewing the Quality Management System (QMS) …
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 and regulators to prove your product currently meets all performance and safety standards. …
MD, IVD, AIMD or SaMD
WEBSoftware that performs image post-processing and analysis to help detect tumors or breast cancer. Software that collects data from multiple sources (x-rays, scans, etc.) and turns that data into 3D models. Software that collects data, then uses algorithms to develop a …
The FDA submission process: 510K vs PMA. What’s the difference
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 submissions typically take longer to secure and require more evidence such as clinical …
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 following a string of high-profile product failures. The effect was to improve the quality …
What's new for medical device manufacturers in iso 14971:2019
WEBWithin the new 2019 revision of the standard, section 7.4 asks companies to assess and document whether the medical benefits of the device outweigh the residual risks. ISO 14971:2019 does not change the overall risk management process, but it does, for the …
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 is set to improve individual and public health outcomes. New investment is flooding into …
GXP compliance: everything you need to know
WEBA guide to GxP compliance. 1. What is GxP? GxP refers to the ‘good practice’ guidelines and regulations created to ensure that food, medical devices, drugs and other life science products are safe, effective and usable. The ‘X’ in GxP can refer to a number of …
MDSW, IVDR, MDR and the new guidance from the EU
WEBAs the 2020 deadline for compliance with the EU’s new Medical Device Regulation (MDR) fast approaches, the EC’s Medical Device Coordination Group (MDGC) has just issued new guidance which further clarifies which types of software are likely to come under its …
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 validation is a key part of GMP (Good Manufacturing Practice) and the management …
What is an Electronic Document Management System (EDMS)
WEBAn Electronic Document Management System (EDMS) is a software that centrally stores and organises documentation in one digital repository. Types of EDMS include ‘self-built’, proprietary ‘on-premise’, and cloud-based solutions. The objective of an EDMS is to …
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 process of constant, internal review. Good CAPA management is all part of this proactive quality …
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 Focus. A graphical Quality Management system necessarily focuses on the relationship between …
5 critical success factors for a new product development process
WEB5 critical success factors in NPD. 1. Product development is a team game. Startups often have the advantage of being small - staffed by multi-skilled individuals in a constant state of collaboration working on one killer product that they hope will change the world. But …
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 (CGMP) regulation for human pharmaceuticals - specifically in Title 21 of the Code of …
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, description of the defect, and whether it is of internal origin or a customer complaint. …
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