The company advances precision CNC machining for medical device components with ISO 13485–aligned quality control and ...

The ISO 13485:2016 training course presents a key market opportunity for medical device organizations to enhance their quality management systems, ensuring compliance with industry and regulatory ...

ZAVENTEM, Belgium, May 20, 2025 (GLOBE NEWSWIRE) -- SYNDEO Medical, a Belgian-based developer of interventional procedure solutions, is pleased to announce that it has received ISO 13485 certification ...

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 ...

Medical device companies MUST have established risk management processes that comply with ISO 14971. And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. ISO ...

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...

Medical laboratories are an integral part of the healthcare system. They supply crucial diagnostic data that underpins disease detection, patient care, and public health management. The quality of lab ...

ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) have just published a new guide to help standards writers address safety aspects in medical ...

Rellingen, September 18, 2025 – Viromed Medical AG ("Viromed"; ISIN: DE000A3MQR65), a medical technology company and pioneer of cold plasma technology, has received the ISO 13485 certification. This ...