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 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.