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Medical device single audit program (MDSAP) TÜV SÜD
WEBThe objective of MDSAP is to develop, manage, and oversee a single audit program that allows a single regulatory audit of a Medical Device manufacturer, conducted by an MDSAP recognised auditing organisation, to satisfy the needs of multiple regulatory jurisdictions. The participating regulatory authorities hope to achieve more consistency
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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 and health of both employees and other personnel. Introduced in March 2018, ISO 45001 marks a significant step forward in the overall effort to improve occupational health and
ISO 45001 Certification
WEBISO 45001 was published in March 2018 by the International Organization for Standardization (ISO), and it supersedes the OHSAS 18001 standard. ISO 45001 is the first international standard to provide a comprehensive OH&S management systems framework. The standard defines requirements for an OH&S system and includes an …
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 changing regulations. Building trust starts with ensuring quality, safety and sustainability. TÜV SÜD can support you in adopting a holistic approach to compliance, product
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 system performance and reducing costs. IMS certification means that certification for multiple management system standards is usually evaluated in a single, comprehensive audit.
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 product meets the necessary standards for market access. Mandatory Requirement: Obtaining CE marking is mandatory for manufacturers, importers, and retailers who
DIN EN 15224 Quality Management System in Healthcare TÜV SÜD
WEBThe DIN EN 15224 Quality Management System is a sector specific standard of quality management for healthcare organisations. It is based on the ISO 9001 standard and it includes tangible requirements for patient safety and management of clinical risks in the planning, realisation and management processes. The DIN EN 15224 system brings …
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, MDSAP, quality, management systems, you name it. Even a rich portfolio on cybersecurity and sustainability courses are at your reach. Management Systems and Productivity Tools.
Healthcare TÜV SÜD
WEBHealthcare. The landscape for hospitals and healthcare providers has changed enormously over recent years. As the market becomes increasingly privatised, competition increases. Patients looking for individualised care are highly selective when it comes to choosing healthcare providers. Good Dialysis Practices GDP Certification.
Differences Between ISO 45001 & OHSAS 18001 TÜV SÜD
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 and health of both employees and other personnel. ISO 45001 replaced OHSAS 18001, which is currently used by over 100,000 organizations worldwide, as the primary OH&S …
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 asset management) into a single, overall comprehensive, and harmonised management system. The combined approach provides a valuable overview of important business …
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 discusses the opportunities and challenges faced by device manufacturers seeking to bring new technologies to market, including medical devices incorporating
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 issues. 3. Reduce overall cost of health and safety-related incidents. 4. Reduce the downtime and cost of disruption in operations.
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 quality of peoples’ lives by reducing health risks and improving their well-being. Patient-centric services such as remote monitoring and checks are customised to the
Nationally Recognized Testing Laboratories (NRTL)
WEBA Nationally Recognized Testing Laboratory (NRTL) is an independent organization that certifies products for the North American market and is recognized by the authorities in the United States and Canada. The NRTL certificate provides clear evidence that your electrical and electronic products comply with the required standards of the North American market.
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 1973 (“DM 21 March 1973”) on the Hygiene rules for packaging, containers and utensils intended to come into contact with foodstuffs or personal-use products. The amendment …
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