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The Crucial Role of FDA and Design Controls in Medical Device

WEBThe U. S. Food and Drug Administration (FDA) and Design Controls play a role in this process, forming the very backbone of medical device development. These …

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URL: https://www.tuvsud.com/en-us/resource-centre/blogs/medical-devices/the-crucial-role-of-fda-and-design-controls-in-medical-device-development

Healthcare and Medical Devices TÜV SÜD

WEBThe healthcare and medical devices sector is undergoing rapid changes driven by several trends and challenges that include technological advancements, increasing costs and …

Category: Medical Go Health

Healthcare TÜV SÜD

WEBHealthcare. The landscape for hospitals and healthcare providers has changed enormously over recent years. As the market becomes increasingly privatised, competition …

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ISO 45001 Occupational Health and Safety Management System …

WEBISO 45001 is an international standard that specifies requirements for an occupational health and safety (OH&S) management system, which is intended to improve the safety …

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Smart Healthcare TÜV SÜD South Africa

WEBSmart healthcare is the integration of fragmented healthcare delivery mechanisms; it utilises electronic patient records and streamlines processes with the aim of improving the …

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Professional training courses for healthcare and hospitality industries

WEBOur suite of training courses for the medical, health and hospitality industry are carefully selected to ensure you are covered when it comes to Medical devices, MDR, IVDR, …

Category: Medical, Course Go Health

Process Hazard Analysis

WEBProcess Hazard Analysis (PHA) reduces the risk of catastrophic events like fire, explosions, and the release of toxic chemicals and hazardous waste. An integral part of Process …

Category: Health Go Health

Artificial Intelligence in Medical Devices TÜV SÜD

WEBTÜV SÜD has published a new white paper under the title of “Artificial Intelligence in Medical Devices – Verifying and validating AI-based medical devices”. The publication …

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Integrated Management Systems (IMS) Certification TÜV SÜD

WEBAn IMS increases efficiencies through the use of simplified processes and documentation, thereby eliminating the elemental approach, lowering effort duplication, improving …

Category: Health Go Health

Understanding CE Marking in the EU TÜV SÜD

WEBDefinition: CE marking is a certification mark that indicates a product’s compliance with essential health and safety requirements set forth by EU directives. It signifies that your …

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Nationally Recognized Testing Laboratories (NRTL)

WEBTÜV SÜD is an accredited NRTL certification provider, and an ISO/IEC 17025:2017 certified laboratory. We offer a personalized one-stop solution designed to meet your …

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Italy amends requirements for food contact stainless steel

WEBOn 11 December 2015, the Italian Ministry of Health published Decree 195 of 6 August 2015[1] in the Official Gazette of Italy, amending the Health Ministry Decree of 21 March …

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Ensuring the Safety of Implantable Medical Devices in a …

WEBTo address the specific safety challenges associated with implantable medical devices in the MR environment, the agency issued in 2021 an updated version of its guidance …

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ISO 45001 – Occupational health and safety management …

WEBTÜV SÜD IS0 45001 – Occupational health and safety management system 5 High level structure ISO 45001 uses the ‘high level structure’ (HLS), so that it has a …

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ISO 45001 OHSMS Certification TÜV SÜD in India

WEBThe benefits of ISO 45001 certification are: 1. Employee safety, risk reduction and injury prevention. 2. Improve an organisation’s capability to respond to regulatory compliance …

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Integrated management systems (IMS) TÜV SÜD

WEBAn integrated management system (IMS) combines various management systems (e.g. quality, environmental, occupational health and safety, information security, energy and …

Category: Health Go Health

Understanding the new EU Battery Regulation TÜV SÜD

WEBIn July 2023, a new EU battery regulation (Regulation 2023/1542) was approved by the EU. The aim of the regulation is to create a harmonized legislation for …

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White Paper Understanding CE Marking in the European …

WEBCE marking is a certification mark that serves as a visual indication of product compliance with EU regulations on health, safety, and environmental protection.

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