Medical Device

The regulatory process surrounding medical devices now 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.

Regulatory Affairs

Compliance Assurance

Quality Assurance

Remediation Strategy and Support

Strategic Consulting

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:

Regulatory Affairs

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.

Strategic Consulting

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.

Quality Assurance

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:

Compliance Assurance

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.

Remediation Strategy and Support

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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