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

Our team of over 500 industry experts — including former FDA officials and other 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. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such as:

  • Anesthesiology
  • Cardiovascular
  • Combination Devices
  • Dental
  • Ear, nose and throat
  • Gastroenterology
  • General hospital
  • Gynocology
  • In Vitro Diagnostics
  • Orthopedic
  • Radiology
  • And more

Regulatory Compliance Associates® Inc.’s breadth of expertise in the Medical Device industry is globally renowned and in demand. Our broad range of regulatory services include regulatory support such as:

 

About RCA

Regulatory Compliance Associates® Inc. (RCA) provides worldwide 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-and globally-regulated companies.

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

Thanks to our expertise in working with FDA officials and global regulatory authorities, you can count on RCA to offer the most efficient, in-depth solutions for your regulatory affairs needs. Our offerings include pre- and post-submission support, recall and complaint management, training services and more.
RCA will also help you navigate through strategies and analyses for your business, aid in a remediation response plan or support the due diligence process in the event of an acquisition. Whether you need strategies for new product development, end-of-life cycles or personnel assessments, count on us to provide an ideal consulting solution for your business.
Our team of leading quality assurance experts will work with you to ensure your business continuously improves and reaches its goals through increased quality assurance. Our array of quality assurance solutions includes:
With increased scrutiny from the FDA and other regulatory agencies, companies in the medical devices industry are frequently implementing compliance assurance strategies. RCA's consultants will help you prepare for audits and assessments, as well as develop a response to FDA findings to achieve the most effective compliance practices.
RCA is renowned for our ability to aid companies in even the most challenging regulatory situations. We help you implement the ideal action plan for your situation with our experts' advanced industry knowledge and hindsight. When you work with us to care for your remediation needs, you can be assured you'll receive the personalized care and quality solutions you need the most during this time.

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