Medical device manufacturers have to prove compliance of their products to US and European authorities (FDA respectively notified bodies). They have to submit an extensive technical documentation, also referred to as the technical file, that includes documents such as
Does this list rather scare you?
Within a few days our experienced experts will help you to get your "software documentation" IEC 62304 and FDA compliant. We examine your situation and tell you exactly within two days what you have to do to document your software compliant with IEC 62304 and FDA requirements.
Within a few days our experienced risk management experts will help you to get your risk management file ISO 14971 compliant. We evaluate your current documents and products and tell you exactly within two days what you have to do to have an ISO 14971 and FDA-compliant risk management file.
We help you compiling a clinical evaluation that complies with European and US regulations and helps to quickly and safely get market approval for your medical device. We will study your clinical evaluation and tell you exactly in two days what you have to do to achieve compliance with regulatory requirements.
No need to be scared! The Johner Institute is specialized to quickly and cost efficiently compile and review these documents.
All of Johner Institute's customers (these are hundreds) passed passed the approval process including audits, inspections and submission in the first shot. Want to learn more?