They have to submit extensive technical documentation, also referred to as the technical file, that includes documents such as
- Device description
- Instructions for use
- Description of intended use/purpose
- Stakeholder requirements
- Product requirements and specifications
- Architectural design charts, construction drawings, circuit board layouts
- Software file including software requirements specification, software architecture, software detailed design, software unit, integration, and system testing (plans and results)
- Risk management file including risk assessment, risk policy, risk analysis, risk mitigation
- Usability / human factors engineering file e.g. use specification, usability specification, use scenarios, formative and summative testing (plans and results)
- Clinical evaluation
- Product classification
- Declaration of conformity
- and much more.
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.
Risk Management File
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
The clinical evaluation is an ongoing process both during development and after the medical device has entered the market. The clinical evaluation aims to demonstrate the safety, performance, and clinical benefit of the medical device. To do so, the clinical evaluation systematically collects and evaluates all available information.
Verity Compliance helps you to compile these documents
No need to be scared! The Johner Institute is specialized to quickly and cost-efficiently compile and review these documents.
All of Verity Compliance’s customers (these are hundreds) passed the approval process including audits, inspections, and submission in the first shot. Want to learn more?