Nettet3. mar. 2011 · Re: Definition of "Legal Manufacturer" "manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging and … Nettet28. sep. 2024 · Informs the manufacturer in the event of non-conformity, incidents. 4. Distributor. Definition of distributor. Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.
Manufacturer - ECHA - Europa
NettetExamples include: Unique Device Identifier (Definition 15), clinical data (Definition 48), clinical evidence (Definition 51), and serious incident (Definition 65). Obligations of … Nettet3. mar. 2024 · Control of Outsourced Processes Procedure. Published On - March 3, 2024. ShareThoughts ISO 13485. (EN) ISO 13485:2016 Control of Outsourced Process is manufacturer’s responsibilities don’t change with respect to designing and manufacturing a safely performing device even if a related activity is outsourced. handschuhe quicksilver
Medical Devices - Legal Manufacturer and Real Manufacturer
NettetAn identification number for a notified body needs to be placed below the CE mark if it has been involved in the conformity assessment. Exemptions. The legal manufacturer should not place a CE mark on your medical device if it is: a custom-made device – although it must still meet the requirements in the directives and the type of device ... Nettetfor 1 dag siden · This reality in manufacturing makes operational technology distinctly vulnerable — and threat actors have wasted no time exploiting those vulnerabilities. … Nettet5. nov. 2024 · manufacturer and compliance with the applicable Common Specifications (article 48.5). In addition, for innovative class D devices where no Common Specifications currently exist, an in-dependent expert panel must provide its views on the perfor-mance evaluation report of the manufacturer (Article 48.6). 1 For definition see Article 2 … handschuhe s3