Medical Device Regulatory Consulting
Regulatory affairs (RA) is Regulatory Compliance Associates (RCA) backbone, and we handle more 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 regulatory compliance 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 guides you throughout our medtech consultants research and approval process as you meet strict and changing regulations both domestically and globally. We offer a wide range of new product approval support services to help you comply with industry demands and plan mass commercialization, including:
- ISO 13485 and FDA compliance evaluations
- Global regulatory strategies like FDA 513(g) requests and product classifications
- Technical writing such as 510(k) submissions, explanation letters and clinical reviews
- 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:
- Root cause investigation
- Corrective and preventive action support
- Complaint handling
- Recall management
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
U.S. Agent Services
Regulatory Compliance Associates. is a registered U.S. Agent, which allows us to assist international medical device companies trying to seek product approval in the U.S. As a registered agent, we can expertly handle FDA interactions on your behalf with responsibilities like:
- Assisting in FDA communication with the foreign company
- Aiding the FDA in scheduling audits
- Answering questions about the company’s medical data for submission
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 industry 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 RCA® 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 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.
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