Your employee resources - limited?
We supplement your
Specialists for regulatory projects to relieve your team during work peaks | interim replacement for maternity and parental leaves | search for experts worldwide
Your documentation - burdensome?
WE PROVIDE HANDS-ON HELP.
Reconstruction of your technical documentations to the new MDR or IVDR | PMS reports, PS plans, PSUR and SSCP | risk management | biocompatibility | state-of the-art clinical evaluation
but what was
YOUR PRODUCT PIPELINE – SLOW?
WE ARE YOUR PARTNER FOR REGULATORY STRATEGY.
Due diligence for product acquisitions | regulatory input for new product
development | early risk analysis | communication with authorities and
YOUR QUALITY MANAGEMENT SYSTEM – OUTDATED?
WE HELP YOU WITH QMS MODERNIZATION.
State-of-the-art QM-system | person responsible for regulatory compliance (MDR) | train your team members | manage external audits | perform internal audits