GMP and CE Certification
Risk analyses and a 510(k) draft were completed on time; AlvaMed training and templates gave the client confidence to perform future risk analyses themselves.
Design Control Document Templates
AlvaMed developed an approach that made use of detailed, self-tutoring templates for all DHF document types.
Clinical Study Management
AlvaMed effectively conducted the post-market study and is in the close-out process after meeting the client’s enrollment needs.
FDA Registration Case Study
AlvaMed completed the registration for the company and coached the company president in the FDA registration process.
