top of page

OUR SERVICES

Quality Management System Support and Improvement

  • Outsourcing alternative (Interim Management, Short-term Staffing)

  • Procedure Development and Implementation

  • Development of new Quality Management Systems

  • QMS System upgrade

Project Management

  • QMS Mergers (acquisitions)

  • Temporary QMS Support (Hands on)

  • Product and Quality System Standard Implementation

Auditing 

  • Internal Auditing

  • Supplier Audits

  • FDA Readiness/Mock Inspections

  • Due diligence audits

Training

  • Internal Auditor

  • Quality Management System Overview

  • Training on Standard Requirements

  • Risk Management

Quality Management System Development and Improvement

  • 21CFR820

  • 21CFR803

  • 21CFR600 & 610

  • 21CFR210 & 211

  • 21CFR1271

  • ISO 13485

  • ISO 9001

  • AATB

FDA Enforcement Support

  • 483 Warning Letter Response

  • FDA Investigation Preparation

  • FDA Remediation 

Contact

Get in Touch With RISE Device Consulting

Thanks for submitting!

bottom of page