Compliance Risk Assessment Strategies

Internal AuditToday’s medical device companies face more pressure than ever to meet the increasing and evolving demands of an internal audit. Many businesses are implementing a risk assessment internal 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®, 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.

 

Internal Audit Services for the Medical Devices Industry

Using a risk-based approach, Regulatory Compliance Associates® 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
    • 21 CFR 820 Audit
    • ISO 13485 Audit
  • 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.

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

sotera healthSotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

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