For a High-Quality patient service that meets the relevant requirements

Our offerings

stage1 :QMS

  • Introduction / Compliance of Quality Management System (GMP, CFR part 820, ISO 13485 & ISO 9001)
  • Introduction of specific Quality Processes, Procedures and Models that reflect the normative and regulatory requirements (risk analysis, post-marketing surveillance, management of instances of non-compliance/CAPA, etc.)
  • Audits / Spot audits
  • Normative and regulatory monitoring

stage2 :Certification/Validation

  • Validation of special procedures (packaging (ISO 11607 -1& - 2), cleaning (NF S94-091), sterilisation (ISO 11137-1 & -2, ISO 11135,etc.))
  • Introduction of ISO 10993 biocompatibility validation strategies
  • Certification / Validation of equipment (packaging, cleaning, sterilisation, etc.), Computerised Systems
a few facts and figures
71 CE RENEWALS ISSUED
21 INITIAL CE MARKINGS OBTAINED
115 CERTIFICATION/VALIDATION OF EQUIPMENT
news MEDICAL DEVICES