About
Contact us for more information on how we can help you remain competitive and compliant.
quality and regulatory solutions
Quality Systems
Followell Compliance Consultants, LLC has developed quality systems from scratch as well as upgraded quality systems to accommodate new products, new geographies, and changing requirements.
Regulatory Strategy
We use a risk-based approach to recommend solutions for your regulatory needs. Whether you need a consultant on a specific project or supplemental support for your existing team, our regulatory experience will have you covered.
Technical Support
Access to specialized or supplemental technical support is often need for projects. My team can help. We have experience with design history file creation and remediation. Specific experience in plastics and aseptic processing.
What do we have to say?
Compliance Corner
When you need a current resource that can guide your solution, visit the Compliance Corner and stay up-to-date! Make sure you sign up at the bottom of the page, for bi-annual newsletter.
Regulatory Strategy
We use a risk-based approach to recommend solutions for your regulatory needs. Whether you need a consultant on a specific project or supplemental support for your existing team, our regulatory experience will have you covered. Common regulatory needs include:
- Global Regulatory Strategies
- US Agent, Official Correspondent
- Pre-submissions with FDA
- Advertising and Promotion; Claims substantiation
- US Device Submissions
- OEM, Private Label oversight
- EU Device Submissions (MDD to MDR)
- Unique Device Identifiers
- Technical Meetings with Notified Body
- Regulatory Agreement Reviews
- Canada Medical Device License Applications
- Due Diligence – Mergers & Acquisitions
- International Medical Device Dossiers and Registrations
- Independent RA Reviewer
……and much more.
Regardless of your needs, when you contract our services, we will present the options, suggest ways to mitigate risk, and provide the strategy to serve as the road-map to success.
Quality Systems
Quality Systems requirements are published and clearly state what to do. The challenge is that it is not often clear how to do it or what will be acceptable to an auditor. A Quality System must also be maintained and opportunities for continuous improvement should be evident for Quality sake as well as for the good of the business. Followell Compliance Consultants, LLC has developed quality systems from scratch as well as upgraded quality systems to accommodate new products, new geographies, and changing requirements. Call us if you need assistance with:
- Corrective and Preventive Action (CAPA)
- Standard Operating Procedure (SOP) creation
- ISO 13485:20016
- Provide Training
- 21 CFR 211, 820, 600
- Medical Device Single Audit Program (MDSAP)
- Out of Specification (OOS)
- Change Management
- Internal Audits
- Verification and Validation
- Supplier Audits
- Quality System Gap Analysis & Improvement Plans
- Audit Prep for or management of audits performed by FDA, Notified Body or another agency
- Due Diligence – Mergers & Acquisitions
- ISO 14971 and Risk Management
…your unique quality needs.
We can provide support to help your organization demonstrate compliance to the Quality System Requirements. Our approach is to tailor the Quality System to work for your business because we know there is not a one size fits all solution to compliance.
Why Choose Followell Compliance Consultants?
One on one consultation that gives us an opportunity to define your needs and refine how we approach accomplishing them.
We are a recognized solution provider with experience to manage crisis and impact to your business.
We create a strategy to meet your needs.
Get your product to market, and keep it there.
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