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Medical Device Solution

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A medical device solution is a product or service designed to help medical device manufacturers meet regulatory requirements and standards, streamline development and production, manage quality control, and ensure patient safety and product efficacy. These solutions can encompass various areas, including compliance and regulatory assistance (e.g., FDA, MDR), operational software (like ERP and quality management systems), manufacturing and quality control technologies (e.g., machine vision for inspection), and distributors and suppliers of medical equipment and technologies.

Medical Device Solution

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ISO 13485, EN 46003

ISO 13485 is the current international quality management system (QMS) standard for the medical device industry, while EN 46003 is an obsolete European standard that was replaced by ISO 13485 in 2003.
ISO 13485, EN 46003
med device

MDD (Medical Devices Directive)

The Medical Devices Directive (MDD), specifically 93/42/EEC, was the European Union's former regulatory framework for medical devices. It has been repealed and replaced by the more stringent Medical Device Regulation (MDR) (EU) 2017/745.
MDD (Medical Devices Directive)
medical-equipment

MDR (Medical Devices Regulation)

The EU Medical Devices Regulation (MDR) is Regulation (EU) 2017/745, a set of rules that governs the production and distribution of medical devices within the European Union. It replaced the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) to improve patient safety and device
MDR (Medical Devices Regulation)