Compliance Assurance

Medical Device Compliance Consultant Services


Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators and need for healthcare compliance consulting.  Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates (RCA®) can provide regulatory compliance consulting support to ensure your company’s needs. We respond quickly and thoroughly by developing sustainable compliance strategies based on each individual market.


Our network of over 500 compliance consultant industry veterans & medical device consultants offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry. We provide a range of Medical Device Compliance Assurance services, including:




One of the best ways to avoid a medical device compliance crisis is through prevention — and we have the compliance consultant expertise needed to help. At RCA, our quality consultant & compliance consulting professionals can identify and assess any outstanding issues and deficiencies to plan an ideal compliance solution. Our variety of assessment services includes:


  • Quality infrastructure
  • Maintenance and facility
  • GMP, ISO, CAPA and PAI
  • Due diligence services




Conducting a regular medical device audit is an ideal way to ensure alignment with changing regulations, including ISO and internal standards. RCA has comprehensive experience in providing regulatory compliance consulting audits to cover a range of concerns. Our compliance consultant team is ASQ-CQA certified and Exemplar Global certified audit professionals available to assist you with auditing services:


  • GMP Part 820 and ISO 13485 quality systems
  • Internal
  • Supplier
  • Pre-approval
  • Contract manufacturer


Preparation and Training


If you’re preparing for an FDA inspection, you’ll need to do more than just hope for the best. RCA helps you thoroughly prepare for your next inspection with tools like mock inspections, facility preparation, and staff training. Feel ready and confident for inspection day through Regulatory Compliance Associates services such as:


  • Front and backroom logistics and management
  • Facility tour preparation
  • Mock inspections and gap assessment
  • Personal behavior coaching
  • FDA readiness inspections


Regulatory Agency Action Response


We know that a compliance failure can have an immediate and lasting effect on your business, and we’re prepared to step into action immediately to help you navigate adverse findings during an inspection or an FDA warning letter. Our range of remediation services allows you to relax knowing that your business is in good hands.


The RCA expert team can assist in the preparation of a response to:


  • FDA form 483
  • Warning letters
  • Consent decrees
  • Import bans


Contact Regulatory Compliance Associates for Quality Consulting Services


Since 2000, RCA has helped thousands of medical device companies around the world navigate the growing complexities and demands of the FDA and other regulatory authorities. We know that a business crisis can significantly impact your business, which is why we offer a unique blend of resources and training to best help you manage them. Whether you’re a local start-up or a Fortune 100 company, RCA is here to assist you with any concerns you might have surrounding your devices’ regulatory compliance.


About Regulatory Compliance Associates


Regulatory Compliance Associates (RCA®) provides medical device consulting & healthcare consulting services to the following industries for the 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. Our life science consultants 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
  • 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 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 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. 



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