Clarity and accuracy are key to ensuring that you communicate effectively with your audience. Clear, precise, unambiguous and accurate writing will also assist in navigating smoothly through the regulatory review process. Some examples of technical reports that we generate:
- Instructions for Use
- Technical Files
- Design Dossiers
- Summary Reports for pre-clinical testing
- Pre-FDA meeting documentation packages
- Annual Reports
- Clinical Evaluation Reports
- Substantial Equivalence Assessments and many more
Regulatory Affairs ›
Considering the global regulatory impact of operational and business decisions on the business is key to the success of the business ...Read more ›
Design Assurance ›
The product development process is a structured approach, which if adhered to, can have significant influence on a smooth regulatory approval process ...Read more ›
Clinical Affairs ›
Depending on the novelty, intended use and risk level of your medical device, you may need to perform a clinical investigation ...Read more ›
