TORONTO, ON / ACCESSWIRE / June 22, 2022 / AI/ML Innovations Inc. (CSE:AIML)(OTCQB:AIMLF)(FWB:42FB), a company committed to acquiring and advancing Artificial Intelligence/Machine Learning ...

Quality management system standards are a great tool for organizations wanting to plan an effective and efficient quality management system. ISO 13485, the ISO standard for medical device quality ...

The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...

The Food and Drug Administration (FDA) issued a Final Rule to amend device current good manufacturing practices (CGMP) requirements of the Quality System (QS) regulation to harmonize the requirements ...

New generations of small medical electronics devices demand the highest levels of quality and reliability For EMS providers and contract manufacturers, the International Standards Organization (ISO) ...

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Statistical Process Control" conference to their offering. This two-day workshop provides the information you need to ...

This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

DENVER--(BUSINESS WIRE)--HeartHero, Inc., a medical device company developing a revolutionary and disruptive Automated External Defibrillator (AED), announced today that the company received ISO 13485 ...