Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
€50.00
Medical supply units
€77.00
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific
€21.00
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) Amendment 1: Climate action changes
This product is not for sale, please contact us for more information
Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
Guidance for assessment and evaluation of changes to drug delivery systems
€208.00
Medical devices — Post-market surveillance for manufacturers
€225.00
Medical devices — Information to be supplied by the manufacturer
€259.00
Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices
€94.00
Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
€65.00
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
€166.00
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
€163.00
Information supplied by the manufacturer of medical devices
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
