Within a constantly transforming regulatory environment, AlisPharm advocates medical device to manufacturers, from the initial development stages of their products all the way to their eventual implementation & operationalization, in order to flawlessly meet all the needs of the specified target institutions. 

 

Puce Ap Quality & Regulatory

  • Creation or updating of documents dealing with production, directives, technical folders, EC labelling, etc. 
  • Project Quality Assurance
  • R&D Quality Assurance
  • Design Control

 Audit and consultancy

  • To meet standards ISO 13485, 21 CFR 820
  • Risk analysis and usability management

 Assistance for drawing up and/or updating of dossiers EC labelling 

  • EC labelling dossier, 510 (k) submission

 Process Engineering

  • Definition of validation strategies: master plan
  • Process validation (machining, special processes, cleaning operations: NF S 94-091, stérilisation Gamma ETO : NF S 94-091, sterilization, gamma radiation, fumigation by ethylene oxide ETO: ISO 11135 et 11137, ISO 11135 et 11137, manufacturing, packaging ISO 11607-1 and 2, Biocompatibility: ISO 10993-1, etc.)

Puce Ap Clinical Studies

  • EC labelling, 510K and international procedures
  • Management of abnormalities, change control and non-conformities
  • Proposed methods for problem solving
  • Customer claims
  • Preparation of inspections and self-monitoring

 Reliability of processes and systems

  • Systems reliability enhancement (equipment and procedures) : Risk analysis, continuous improvement, retrospective / periodic qualification and validation
  • Qualification and initial validation of equipment (production, packaging and control), rooms and facilities (e.g. autoclaves, washing machines, production systems, facilities, filling machines, environmental systems, etc.)
  • Risk analysis management
  • Validation of computerized systems