ISO 13485 Implementation Services

Whether you are just beginning your journey to certification or you are faced with aggressive timelines to meet the ISO13485 or MDR transition deadlines, RCA’s quality assurance experts can help. 

• Quality System Implementation
• Quality System Transition
• Standard Operating Procedure (SOP) Development
• Document Control Implementation
• Design Controls
• Design History File Creation
• Risk Management (ISO14971)

RCA can provide needed Medical Device expertise and services in the following key areas:

• • Quality Assurance
  • Data Integrity & GMP Consulting
  • Outsourced Quality Support
  • MDSAP: Medical Device Single Audit Program

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].