QA is the heart in development of Medical Device, In Vitro Diagnostics, Software, Pharma & Biotech

We support hundreds of small and mid size Companies in the areas of Medical Device, IVD, Pharma, Biotech and Software with QA. We can provide an experienced QA Manager part time, your first eQMS or a transfer from your paper based eQMS, all audits and inspection readyness and much more. In Pharma and Biotech we support Companies with audits and training in all GxP areas from GLP, GCP, GMP, to GVP. In Device and IVD we can be your PRRC, Perform GAP analyzes of your QMS (MDR, ISO 13485, ISO9001, ISO 14001, QSR, etc.) Internal audits, supplier audits and mock inspections, Support at Notified Body audits, Management review, Supplier evaluations

Meet our Directors on the 1st of June for lunch or send us a mail for a quick Teams meeting.  Contact me on jan.hellqvist@key2compliance.com