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 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 consulting for in-depth and up-to-date regulatory insights which increase speed-to-market.


As trusted medical device regulatory consulting experts, RCAs’ employees are here to help you navigate the difficulties associated with new product submissions. RCA’s medical device consulting team has expertise in both the approval process and post-approval support. Our broad range of medical device regulatory 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. At Regulatory Compliance Associates, our medical device consulting Experts will guide you throughout the approval process to meet regulatory compliance standards. We offer a wide range of new product approval support services to help you comply with regulations, including:


  • ISO 13485 and FDA compliance evaluations
  • Global Regulatory Strategy & Pre-Submission Support
    • FDA 513(g) requests and product classifications
    • Combination Products
  • Domestic/International Regulatory Submissions
  • Data integrity during technical writing (e.g. 510(k) submissions, explanation letters, clinical review)
  • Establishment Registration and Device Listing
  • Medtech consulting for artificial intelligence & software as a medical device (SaMD)


Post Approval Support


RCA’s team of medical device regulatory consulting Experts are here to ensure your approved products remain 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, via 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 regulatory consulting services can provide the same levels of client support. From small special projects to ongoing assistance, we offer additional regulatory compliance services to fit our client’s needs. RCA will customize a unique medical device consulting solution based on your product and business goals. 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 these medical device regulatory consulting services:


  • MDR consultants perform a comprehensive review of product portfolios & certificate expiry dates
    • Data Integrity
  • Medical device manufacturing consultant gap assessments for conformity
    • Quality Metrics
  • 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
    • Risk Management Plan
  • IVD regulatory consulting to determine predicate devices & clinical strategy


About RCA’s Medical Device Consulting Services


The regulatory compliance process surrounding the medical device industry involves strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through your product’s regulatory clearance/approval.


Our team of over 500 medical device regulatory consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start-ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483s, import bans, or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.




For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.


At Regulatory Compliance Associates, we offer a wide variety of services for medical device security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medtech consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.


  • SaMD Consulting
  • Threat Modeling
  • Proof of Concept
  • Quality Assurance Services
  • TIR 57 & TIR 97
  • ISO 62304
  • ISO 27001


Regulatory Affairs


Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights that increase speed-to-market.


As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 


  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products


Compliance Assurance


Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.


Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offer a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.


  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity


Quality Assurance


Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.


In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.


With more than 20 years of experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.


  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • Facility Validation
  • Equipment Validation
  • Quality Metrics


Remediation Services


Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges has a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters, and Consent Decrees.


  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services


Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.


  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP


Strategic Consulting


Whether it’s strategy, a technical plan, or a project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful experience. Regulatory Compliance Associates® medical device consulting can deliver your strategy project on time, and on budget, so you’re never embroiled in a costly mistake.


Our medical device consultant Experts are industry Experts who are here to provide the unique insight you need before an M&A deal, through a staffing crisis, and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.


  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information


About Regulatory Compliance Associates


regulatory consultingRegulatory Compliance Associates® (RCA) provides medical device regulatory consulting to the following industries for resolution of life science challenges:



We understand the complexities of running a medical device regulatory consulting 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, Regulatory Compliance Associates 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 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.


Commitment to Quality


Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.



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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