Remediation Services

Regulatory Compliance Associates is widely recognized within the life science industry for its ability to help companies successfully resolve complex regulatory challenges, including remediation services. With a proven track record of medical device remediation success, our life science consultant Experts have significant experience developing responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

About RCA’s Medical Device Remediation 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. Each QMS consultant negotiates difficult demands of remediation services with insight and the clear advantage of our unique expertise and experience. that makes partnering with Regulatory Compliance Associates a competitive differentiator in the remediation space.

Quality System
- Design Strategy Consulting
- ISO 9001 Consultant
- Quality System Consultant
Technical File and Design History File (DHF)
- DHF Consultant
- Design Consultant
- Design Engineer Consultant
- Mechanical Design Consultant
- Product Design Consultant
Data Integrity
- Process Design Consultant
- Operations Consultant
- Experience Design Consultant
Regulatory Action
- Regulatory Consultant
- Sustainability Design Consultant
Manufacturing and Facility Validation
- Manufacturing Consultant
- Electrical Design Consultants
- Electronic Design Consultants
- Industrial Design Consultant
21 CFR Part 11 & Computerized System Validation
- Design Engineering Consultant
- Service Design Consultant
Software as a Medical Device (SaMD)
- SaMD Consultant
- Design Innovation Consulting
- Design Thinking Consultant
- Graphic Design Consultant
- Human Centered Design Consulting
- Software Design Consultant
- User Experience Consultant

Medical Device Consulting

Regardless of where you are in your medical device’s lifecycle, even one medical device remediation issue can be a major setback. When remediation is required, it can pose distinct challenges that your company and team may not be fully prepared to successfully navigate. For this reason, it’s important to get the targeted help you need to keep your medical device’s development on track.

FDA Regulation

FDA regulations are constantly changing and developing, and the medical device industry is developing products faster than ever before. So it’s understandable that the path to market for your product can seem more like a moving target than a clear and set route. In addition, depending on where you intend to market your product, international regulatory changes — like the new EU Medical Device Regulation (MDR) that went into force in May 2024 — can cause previously unforeseen compliance issues.

Corrective and Preventative Action (CAPA)

When you need medical device remediation support, especially when a Corrective and Preventive Action (CAPA) plan is required, achieving continuous and positive progress in your medical device’s development is essential. Otherwise, you could wind up back at the starting blocks instead of drawing closer to the finish line.

Fortunately, even if you and your team are in uncharted territory, forming a strategy to bring your company and product back into compliance is exactly what we’re all about. Our more than 500 associates are all seasoned professionals. Regulatory Compliance Associates experts assigned to remediation services projects have the know-how and insights to help you form, execute, and adhere to a strategy that brings you back into compliance in the most efficient manner possible.

Medical Device Remediation

Whether you’re looking to market a new implantable device to the European Union or looking for FDA clearance on a new infusion pump, Regulatory Compliance Associates is known for helping medical device manufacturers through the most challenging remediation services. By forming an action plan with our knowledge of the regulatory landscape, you can take advantage of our collective experience in order to apply it proactively to your remediation requirements at a time when solutions matter the most.

Get to Market Sooner With Regulatory Compliance Associates

Medical device manufacturers can help medical professionals save lives and improve the quality of life for their patients. But these positive results can only be achieved if they first successfully navigate the regulatory challenges that lie ahead of them on their way to market. This is why the team at Regulatory Compliance Associates, with experts that include former FDA officials and other leaders in the medical device regulatory field, can make a significant difference in the success of companies ranging from startups to international Fortune 100 companies.

About RCA’s Medical Device Consulting Services

The regulatory compliance process surrounding the medical device industry involves a 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 medical device consultants can help 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 medical device consultant 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 483’s, import bans or consent decrees. Very few medical device consulting companies have the same regulatory compliance expertise in a variety of medical fields.

Cybersecurity

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 devices 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 medical device 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.

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 medical device regulatory 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 which 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 services for an adverse event, Regulatory Compliance Associates^® can help.

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers 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 medical device consultant assistance you need to monitor these processes and ensure quality compliance every step of the way.

With more than 20 years 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
MDSAP
Facility Validation
Equipment Validation
Quality Metrics

Regulatory Compliance Associates^® is widely recognized within medical device consulting companies & the life science industry for remediation service & support. RCA’s ability to help companies successfully resolve complex regulatory challenges have 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 services 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 a strategy, a technical plan, or project, Regulatory Compliance Associates^®medical device consultancy can help ensure a successful project. Regulatory Compliance Associates^® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

Our medical device consultant Experts are industry Experts 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

remediation services Regulatory Compliance Associates^® (RCA) provides medical device consulting to the following industries for resolution of life science 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, 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
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.

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