QMS/RA Consulting

Makromed, Inc. has extensive years of experience ​in the medical device industry. We are fully engaged with the customers’ needs to meet the regulations and improve their processes.

We offer a variety of consulting services, including the following:

• Process & Test Method Validations
• Software Validations
• Risk Management
• Statistical Techniques / Biostatistics
• Design Controls - DOE / Reliability
• CAPAs / Six Sigma Tools
• QSR / MDR / ISO 13485 Audits and Training
• 510(k) and De Novo Submissions on Software-driven Devices