GEMAR is well known in the area of US and European quality management systems compliance.
GEMAR performs on-site quality system audits for compliance to US requirements to help clients prepare for FDA inspections, and provides advice on corrective action programs.
In addition, GEMAR can help your company achieve certification to ISO 13485 and compliance with the relevant European Directives.
GEMAR can also assist you in the development, implementation and certification of quality systems to Canadian requirements and in preparing for Health Canada inspections, and also for Japanese Ordinance 169 quality system inspections, the requirements of which are based on ISO 13485.
Feel free to contact us and see how we can assist you.