Compliance Risk Assessment Strategies

Today’s medical device companies face more pressure than ever to meet the increasing and evolving demands of regulators. Many businesses are implementing a risk assessment audit to identify insufficiencies, evaluate risks and determine inspection readiness. These strategies smooth the inspection process and provide a greater chance of success.


Conducting periodic internal audits is one way that many companies choose to ensure compliance with ISO standards, cGMPs and international regulations. At Regulatory Compliance Associates® Inc., we have extensive expertise with both short, targeted internal audits and more substantial assessments across the quality management system. No matter what your goals may be, we have resources available that will meet your needs and increase your inspection preparedness.


Auditing Services for the Medical Devices Industry

auditUsing a risk-based approach, Regulatory Compliance Associates® Inc. will help your company identify and correct compliance deficiencies and choose the best audit solutions for inspection readiness.


ASQ-CQA or Exemplar Global certified auditors are available for the following:


  • Supplier Audits
  • Current Good Manufacturing Practices (cGMP) Compliance Audits: Manufacturing, Pilot Plant, Laboratory Facilities
  • Current Good Laboratory Practices (cGLP) / cGMP Compliance Audits
  • Regulatory Gap Analyses
  • Risk Assessments
  • Pre-Approval Audits
  • CFR Part 11 Gap Analysis
  • Development of Inspection Checklists
  • Quality Systems
    • 820 Audits
    • ISO 13485 Audits
  • Internal Audits
  • Contract Manufacturer Audits
  • Supplier Audits
  • MDSAP Compliance Readiness Assessments

The RCA Advantage

Compliance gaps can sometimes blindside even the most prepared medical device companies during agency inspections. Teaming with RCA ensures you’ll be as prepared as possible to face scrutiny from regulatory bodies.


As an industry-leading risk assessment consultant, we offer a host of benefits you won’t find anywhere else:


  • Our staff are seasoned audit experts — many have decades of experience working with the FDA and preparing for FDA inspections. We offer these unique insights and in-depth knowledge to your business so that you know exactly how to plan for your inspection.
  • We not only have the knowledge and means to perform thorough audits, but we also have the processes in place to help you make sense of findings and manage the corrective action process.
  • Not only does our team monitor the little problems that regulatory agencies are likely to uncover, but we also take care of the big picture as we ensure the compliance of your overarching quality system.

Contact RCA for Your Medical Device Compliance Assurance Services

Since 2000, Regulatory Compliance Associates® Inc. has helped thousands of companies successfully prepare for FDA and MDSAP audits and navigate the increasing demands of industry regulations with an array of auditing services. Our team of FDA veterans and industry experts has unique insight into the inner workings of leading regulatory bodies, and we can help you overcome regulatory challenges with a solution designed to meet your goals and industry needs.


If you’re ready to see what a top-quality risk assessment consultant can do for your business, then contact us today or use the form below to receive more information or request a service.

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