I. R.A. biomedical devices

EXCELLENCE IN EXCELLENCE SECTOR

The consulting activities is aimed to define the modalities to plan, validate and control medical devices in accordance with EU directives, the ISO 9001: 2008 and ISO 13485: 2004. The main consulting activities consist of:

PLANNING CONSULTING:

  • Startplanning
  • Planning anddefinitionof the productplan
  • Design verification
  • Preliminary risk assessment
  • Reviews of thedesign
  • Design checks
  • Design validation

CONSULTING FORCE MARKING:

  • Preparation of technical files with models already approved by the Notified Bodies
  • Risk analysis in accordance with ISO 14971
  • Check list of the Essential Requirements in accordance with Annex 1 of the DDM
  • Preparation critical report of Eligibility based clinical documentation (literature)
  • Declaration of Conformity according to DDM
  • Assistance during the inspection the Notified Body or Certification

CONSULTING TO VALIDATE THE MANUFACTURING PROCESSES:

  • Validationprocessof manufacture ofMedical Devices
  • Validation ofsterilization processestoEtoin accordance with ISO11135, by irradiationY, βin accordance with ISO11137, in accordance withSteam ISO11134
  • Validationprocess ofsingle packagingin accordance with EN868-1-5withaccelerated aging.
  • Shelf-lifeof medical deviceswithaccelerated aging studiesandqualification tests

CONSULTING TO EVALUATION AND CONTROL:

  • Biocompatibilitytestingof raw materials andmedical devicesin accordance with ISO10993-1,
  • Chemical testson substancesvolatileand extractablefrom thedevicesbefore and aftersterilizationby radiationY andβ;
  • Testingofchemicalstability andnon-toxicityof the materials anddevicesbefore and aftersterilizationin accordanceItal. /Eur.
  • ControlresiduesEto(Eto residualhydrochloricethylene, ethylene glycol) inMedical Devicesprior to releasein accordance withISO10993-7
  • Sterility testingonmedical devicesand also withBiological indicatorsaccordingtoItal. /Eur. ISO11137
  • Testingand validationBioburdenrecovery rates,materials, componentsandmedical devicesin accordance with ISO11137
  • LalTest anditsvalidatefor the verificationof the absence ofbacterial endotoxinsin complianceItal. /Eur.

CONSULTANCY FOR THE DESIGN, VALIDATION AND CONTROL CLEANROOM MANUFACTURING:

  • Designing cleanroom manufacturing and defining class project in accordance with ISO 9001: 2000 and ISO 14644-1
  • Validation and periodic monitoring of cleanroom manufacturing, classification of areas in accordance with ISO 14644-1
  • Validation and periodic survey of laminar flow hoods for production and analysis, classification in accordance with ISO 14644-1
  • Validation and determination RecoveryTime (Recovery Time class cleanroom)
  • Validation and detection of physical parameters (T ° C,% RH, pressure, flow rate, air speed, number of spare parts / h)
  • Control of particle contamination in clean room in accordance with ISO 14644-1
  • Control of microbiological contamination in clean rooms (air and surfaces) in accordance with ISO 14968-1 / 2 and GMP Eur.
  • Control microbiological contamination of fluids (water, detergents and disinfectants used in the manufacturing process;
  • Validation and control effectiveness of principals used in the disinfection of surfaces, protective clothing and hands of the operators;
  • Identification and characterization of microbial bacteria, mold and fungi.