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The guidance document "MEDDEV 2.12-1 rev 8" offers a comprehensive guidance on best practice for medical device post-market surveillance (materiovigilance). The concept of post market surveillance is linked to the concepts of vigilance and market surveillance. A manufacturer of medical devices is required to report incidents (serious adverse ...
The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many ...
[2] [3] In 1966 NASA released its FMECA procedure for use on the Apollo program. [4] FMECA was subsequently used on other NASA programs including Viking , Voyager , Magellan , and Galileo . [ 5 ] Possibly because MIL–P–1629 was replaced by MIL–STD–1629 (SHIPS) in 1974, development of FMECA is sometimes incorrectly attributed to NASA. [ 6 ]
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
Since 2003, Johnson & Johnson and Boston Scientific have both claimed that the other had infringed on their patents covering heart stent medical devices. The litigation was settled when Boston Scientific agreed to pay $716 million to Johnson & Johnson in September 2009 and an additional $1.73 billion in February 2010. [ 174 ]
Matthew 2:12 is the twelfth verse of the second chapter of the Gospel of Matthew in the New Testament. The magi , dispatched by King Herod , have found and paid homage to the Infant Jesus . In this verse this they return home rather than to Herod.
Agile software development methods were initially seen as best suitable for non-critical product developments, thereby excluded from use in regulated domains such as medical devices, pharmaceutical, financial, nuclear systems, automotive, and avionics sectors, etc. However, in the last several years, there have been several initiatives for the ...
The analysis of 402,051 hip replacements showed that 6.2% of metal-on-metal hip implants had failed within five years, compared to 1.7% of metal-on-plastic and 2.3% of ceramic-on-ceramic hip implants. Each 1 mm (0.039 in) increase in head size of metal-on-metal hip implants was associated with a 2% increase in failure rate. [64]