Regulatory Affairs

Medical Device Regulatory Consulting


Regulatory affairs (RA) is Regulatory Compliance Associates (RCA) backbone when it comes to regulatory compliance. We handle more medical device regulatory affairs consulting submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, MHRA, EMA and notified bodies worldwide. Therefore, you can count on RCA’s medical device regulatory consulting for in-depth and up-to-date insights which increase speed-to-market.


As trusted medical device regulatory affairs consulting experts, RCAs’ employees are here to help you navigate the difficulties associated with new product submissions. RCA’s medical regulatory consultants have expertise in both the approval process and post-approval support. Our broad range of Medical Device Regulatory Affairs consulting services include:


New Product Approval Support


Regulatory changes are one of the most troublesome challenges facing medical device companies seeking approval of a new product. Regulatory Compliance Associates medical device consultant Experts can guide you throughout the research and approval process to meet regulations both domestically and globally. We offer a wide range of new product approval support services to help you comply with industry demands, including:


  • ISO 13485 and FDA compliance evaluations
  • Global Regulatory Strategy & Pre-Submission Support
    • FDA 513(g) requests and product classifications
  • Domestic/International Regulatory Submissions
  • Technical writing such as 510(k) submissions, explanation letters and clinical reviews
  • Establishment Registration and Device Listing
  • Medical Technology consulting for artificial intelligence & software as a medical device (SaMD)


Post Approval Support


Regulatory Compliance Associates team of medical device development consulting Experts is here to make sure your medical device remains dependable and effective. Our medical device consulting services continue even after it’s placed on the market. Our medical device consultancy post-approval support solutions are designed to ensure that your product is always in compliance, with these regulatory compliance consulting services:


  • Medical Device Reporting/Adverse Event Reporting
  • Recall Management
  • Re-Submission Assessment & Remediation
  • Post Market Surveillance


Other Regulatory Services


At Regulatory Compliance Associates, we understand that no two medical device regulatory consulting services can provide the same regulatory support. From small special projects to ongoing assistance, we offer a range of additional regulatory compliance services and will customize a consulting solution based on your product and unique business demands. Some of our many additional services include:


  • Outsourced regulatory affairs
  • Regulatory affairs training programs
  • Regulatory due diligence
  • Regulatory gap assessment


EU Medical Device Regulation (MDR)


If your company is looking to sell medical devices in Europe, your products will need to comply with new EU Medical Device Regulation (MDR) requirements. Our EU MDR consulting solutions allow Regulatory Compliance Associates to assist you in EU MDR compliance through the following services:


  • MDR consultants perform a comprehensive review of product portfolios & certificate expiry dates
  • Medical device manufacturing consultant gap assessments for conformity
  • Updated MDR documentation medical device regulatory affairs consulting
  • Remediation and implementation of an EU MDR compliance plan
  • IVDR consultant & IVD consulting solutions for low risk & high-risk devices
  • IVD regulatory consulting to determine predicate devices & clinical strategy


Contact Regulatory Compliance Associates for Medical Device Consulting


Since 2000, both small and large medical device companies around the world have trusted Regulatory Compliance Associates as their go-to service for medical device consultants. Our team of over 500 regulatory compliance Experts offers the hindsight and advantage necessary to give you clear guidance from the beginning to end of the product submission process. No matter what your unique industry needs, count on Regulatory Compliance Associates to develop an ideal consulting solution tailored to help you comply with the industry and meet your goals.


About Regulatory Compliance Associates


Regulatory Compliance Associates (RCA®) provides medical device regulatory 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 minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our regulatory compliance Experts.


  • 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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