Medical Device Regulatory Services Handout
Trust the Experts with your Regulatory Services challenge
Whether struggling with a submission strategy and execution or dealing with regulatory compliance, we stand ready to support your medical device regulatory services needs. Our consultants have years of experience as regulatory and compliance leaders and can help establish solutions for any challenges that surface.
Our services highlighted in the handout include:
- US FDA Traditional Regulatory Strategy and Submissions, such as PMA and 510(k)
- Innovative Regulatory Pathways such as De Novo Requests
- Humanitarian Use Device (HUD) and Device Exemption (HDE)
- FDA Pre-Submission Meeting preparation and support
- European Union Technical Files and Class III Design Dossiers
- Clinical Evaluation Reports
- Global regulatory strategy and product classification
- Global registration submissions
Regulatory Compliance Associates® Inc. (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 Southeastern Wisconsin, with offices in West Central Florida; North Central Colorado; and Central Eastern Europe
- Expertise backed by over 500 industry subject matter experts
Regulatory Compliance Associates® Inc. is driven to improve the overall health and well-being of patients around the world by providing expert consulting services tailored to the business needs of its clients.
The RCA Global Difference
- We are the consultants who know how to get things done with quality results, on time and on budget.
- Our expert resources are a strategic blend of top industry veterans, experienced specialists, and stellar consultants to support any project need.
- Our management leaders each have two to three decades in FDA-regulated industries.
We have walked the walk.
- Our approach is differentiated to meet your specific needs.
- We can provide excellent references, case studies, and testimonials.
- Our strategy to execution is priced appropriately.
Why Choose RCA
- RCA is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges.
- By mining regulatory intelligence, RCA continuously evaluates FDA’s current thinking and leverages thought leadership networks to advocate for our clients.
- We know a quality or compliance crisis can significantly impact your business. We have the experience to manage them.
- We have the know-how and proven approach to navigate warning letters, consent decrees, and other situations.
- We know how to partner with your executive, legal, and communication teams.
- We support management to assist with the growing and changing concerns.
- We help navigate the storm and manage the impact to your business.