FDA 483 Observation & Regulatory Response
Due to technological innovations and ever-increasing safety standards, the FDA’s hand on the medical device industry is tightening. The agency outlines a comprehensive framework for companies to follow during their medical device products’ development and manufacturing, but the growing list of demands can make compliance difficult. Over the past several years, the FDA has begun to issue warning letters more frequently, which proves the need for greater understanding of regulatory response and services that help address these demands.
Warning Letter
Receiving a warning letter from the FDA or another regulatory organization can be a confusing time. You may have many questions concerning how to get your business back to compliance, how to pinpoint the underlying problem behind your compliance issues or how to mitigate any potential damage to your company’s reputation. If you’re struggling with the next steps to take after receiving a warning letter or consent decree, Regulatory Compliance Associates® is here to offer guidance and support.
Compliance Consultants
RCA provides flexible compliance solutions backed by our industry experts that have an average of 25 years of experience. Whether you operate a small or large company located in the U.S. or internationally, we’ll help you regain compliance and make sure your compliance crisis has minimal effect on your business.
RCA’s Warning Letter Consulting Services
If you’ve received a Warning Letter from the FDA, RCA® can develop a comprehensive program to address it and any other larger regulatory affairs challenges that may arise with your medical device. We will provide a Project Management Professional (PMP) to lead the program, in addition to engineers with expertise in quality systems and manufacturing engineering to execute the program that coordinates with your resources.
FDA Consultants
Every situation is different and the program’s plan may include aggressive but realistic milestones, as well as supporting tasks, and task dependencies. Many of our FDA consultants have experience in FDA-regulated industries and have the expertise to assist you with:
- 483 Remediation
- Warning Letter Remediation
- Consent Decree Remediation
Compliance Assurance
The most common compliance issues medical device companies face are those concerning corrective and preventive action, reporting and complaint procedures, and non-conforming manufacturing procedures. At RCA, we have a deep understanding of each of these areas as well as the most common issues companies face when trying to comply with them.
Regulatory Strategy
With this extensive knowledge and experience, we can help you better prepare your regulatory strategy, submit to authoritative bodies and understand the complexities surrounding the review period. Even if you must fix several regulatory action issues of compliance on a tight timeline, we have the resources and expertise to help you succeed. We offer a host of regulatory compliance services for the medical device industry, including:
- FDA regulatory classification and strategy
- FDA communications and meeting participation
- New product development
- Mock inspections
- Complaint handling and medical device reporting
- Design controls
When you engage with RCA®, you’ll avoid the need to train or hire employees specifically for compliance tasks — saving you significant time and money. We’ll scale our workforce and services to your business’ needs and budget, so you’ll only pay for the experts you need at the time you need them.
About Regulatory Compliance Associates
Regulatory Compliance Associates (RCA) provides healthcare consulting 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, 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.
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