Whether under official or voluntary action indicated, Regulatory Compliance Associates® Inc. routinely develops and executes scalable, defendable Quality System remediation plans for medical device manufacturers. Regardless of an organizations size, we have engaged with clients to assist in the development of a compliant quality management system as a result of an inspection finding. Firms have relied upon our third party expertise to negotiate systemic Warning Letter corrective action plans, monitor and assess implementation of corrective actions, and remediation efforts.
With a proven track record of success, we have significant experience with the development of meaningful responses with sustainable corrective actions to:
- FDA 483 Observations
- Warning Letters
- Untitled Letters
- Consent Decrees
Our clients depend on us for:
- Preparation of a response that will be accepted by the Agency and be realistic for your organization to execute
- Development of a comprehensive proof book and preparation strategy
- Identify systemic versus discrete concerns, assess their technical validity, and frame comprehensive responses
- “Right size” corrective actions commensurate with organization size, capability and product risk
We Provide the Full Range of Quality System Consulting Services
Staying in FDA regulatory compliance and passing inspections seamlessly require meticulous work and strict attention to detail. In order to succeed in medical device development and approval, your company must adhere to a thorough quality system. Regulatory Compliance Associates provides the customized services you need to resolve any quality and regulatory challenges that arise. These services include:
- Quality system development: We create a custom medical device quality system centered around each client’s product-specific needs.
- Risk management: Regulatory Compliance Associates is well-versed in the art of designing cultivated risk plans that critically analyze products to reduce any risk to the fullest extent.
- Designing device regulatory strategies: Strategy is essential when it comes to preparing to request FDA approval of a medical device. The depth of our expertise positions Regulatory Compliance Associates to map a successful strategy tailored for each client, with the ultimate goal of achieving FDA approval.
- Project management: Each client will receive a project manager to oversee their case and ensure a consistent point of contact. This policy allows for streamlined communication flow and highly efficient project management.
- Post-development services: In addition to front-end consulting, we are able to provide clients with post-production services. These offerings encompass handling warning letter responses and complaints, managing Health Hazard Evaluations and providing Medical Device Reporting services.
How Our Medical Device Quality System Consulting Process Works
In order to effectively manage quality systems for our clients, we follow a tried-and-tested process. This process ensures that our systems are developed around your unique needs and mitigates risks as much as possible. Our consulting procedure includes:
- Identifying your needs: Before developing a quality system, we’ll assess factors such as your industry, location and relevant regulatory agencies.
- Modifying Quality Management Systems for each client: There is no “one size fits all” QMS approach that works perfectly. Rather, we tailor our quality systems to fit the needs and budgets of each client.
- Training staff properly: We ensure each of our team members are fully trained and highly experienced in the field in order to provide the finest consulting services possible. Our team stays informed of any industry changes and updates.
- Mitigating risk: When designing a quality system, evaluating and reducing risk is always a critical concern. Our process includes assessing possible risks throughout a device’s life cycle and strategizing ways to reduce risk while staying compliant with FDA regulations.
Regulatory Compliance Associates® (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.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Regional offices in Florida, Colorado and Europe
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021