Quality Management Systems

We help you setting up a Quality Management System or adapt your system to the regulatory requirements. We have extensive experience in Quality Systems for Medical devices and Software development, both for small businesses and large medical companies.
VISAMED can provide training in Quality Management and Quality Assurance matters.

Europe and Canada

  • Staff and management training on the requirements of ISO 13485
  • Conducting internal audit and designing effective corrective action plan
  • Assisting in the implementation of corrective audit plan
  • Implementation of Risk Management Procedure in accordance with ISO 14971
  • Implementation of Usability Files in accordance with EN 60601-1-6 and EN 62366
  • Development of an effective corrective and preventive action system (CAPA system)

USA (21 CFR § 820)

  • Staff and management training to the requirements of quality system regulations (QSR)
  • Development of an effective Corrective Actions and Preventive Action systems (CAPA system)
  • Implementation of an effective Hazard Analysis and Critical Control Points (HACCP) program
  • Process validation, including facility master plans and assistance in the
  • development of procedures, protocols and reports, In process-controls and sampling, Failure investigation

Supplier Assessments

  • Established a documented supplier evaluation and surveillance system
  • Conducting audits of suppliers of products and services as part of the FDA and European quality systems requirements
  • Assist suppliers in meeting quality requirements