Welcome To F&R Solutions
Keeping MedTech Compliance Simple
MORE ABOUT US
Consultant-Guided Quality Excellence
Establish an efficient, compliant quality system that’s easy to use and ready to grow with your business.
At F&R Solutions, we provide expert guidance to medical device manufacturers, developers, and stakeholders seeking ISO 13485, MDSAP, EU MDR, and FDA 510(k) compliance & certification. With over 10 years of experience, we specialize in internal audits, QMS implementation, regulatory compliance, and risk management to ensure seamless certification success.
100% Client Certification Success Rate
Proven Expertise in Global Regulatory Standards
Tailored Compliance Strategies for Your Business
Customized Consulting, Crafted to Your Needs
We simplify regulatory compliance so you can focus on innovation.
Whether you need ISO 13485 certification, MDSAP audit preparation, FDA QMS implementation, Internal Audits completed,
External Audit representation or SaMD regulatory support, we tailor our services to your unique challenges.
ISO 13485 Certification Support
MDSAP Audit Readiness & Compliance
FDA QSR (21 CFR Part 820) & 510(k) Compliance
Risk Management (ISO 14971) Consulting
UDI, GUDID & FURLS Registration Support
Supplier Audits & Quality Agreements
Regulatory Strategy & Market Entry Support (MDEL, EU MDR, FDA Pre-Submissions)
Digital Health & SaMD Compliance (IEC 62304, AI/ML in MedTech)
Technical Documentation & Audit Preparation
Why Hire Us?
Choosing the right regulatory partner is crucial for your business’s success. Here’s why F&R Solutions stands out:
Industry Expertise: Over 10 years of hands-on experience in medical device regulatory compliance.
100% Certification Success Rate: Every client we’ve worked with has successfully achieved compliance.
Tailored, Hands-On Approach: No cookie-cutter solutions; we customize strategies for your unique needs.
Deep Regulatory Knowledge: Mastery of global compliance frameworks, including ISO 13485, MDSAP, 510(k), MDEL, and UDI compliance.
Long-Term Compliance & Growth Focus: We don’t just help you get certified; we ensure sustainable compliance and business scalability.
End-to-End Quality & Compliance Solutions
Achieving compliance is more than just a one-time process. We help you build a scalable and sustainable Quality Management System (QMS) that adapts as your business grows.
Regulatory Readiness Assessments: Identify gaps and develop actionable improvement plans.
Mock Audits & Pre-Inspection Readiness: Ensure your QMS is audit-ready.
Process Optimization & Automation: Improve efficiency and reduce compliance burdens.
UDI & Device Identification Compliance: Ensure seamless product registration and market access.
Quality Culture Development: Foster a proactive compliance mindset across your organization.
Your Trusted Partner in Medical Device Compliance
Helping You Get It Right, The First Time
Speed up market access and transform quality with our tailored regulatory strategies.
QMS Implementation & Optimization: Build a solid compliance foundation.
Gap Assessments & Internal Audits: Prepare for successful certification.
Market Clearance & Approvals (510(k), MDEL, EU MDR): Expand your global reach.
Regulatory Roadblock Resolution: We mediate with authorities to simplify compliance.
Training & Coaching: Equip your team with the skills needed for regulatory excellence.
“We don’t just offer consulting—we become a part of your team, ensuring compliance without the stress.”
Beyond Compliance: Future-Proof Your Business
Regulations are constantly evolving, and so should your compliance strategy. We help businesses stay ahead of the curve by providing:
Regulatory Intelligence & Updates: Stay informed about changes impacting your industry.
FDA Pre-Submissions & Market Entry Strategy: Prepare for regulatory engagement with confidence.
Post-Market Surveillance & Risk Management: Ensure continued product safety and compliance.
Complaint Handling & CAPA Programs: Proactively address quality issues before they become major concerns.
Supply Chain & Vendor Compliance: Strengthen your supply chain resilience and regulatory alignment.
How It Works – Get Started in 3 Easy Steps
STEP 1: Book a Free Consultation – Speak with an expert to assess your needs.
STEP 2: Get a Customized Compliance Plan - Receive a roadmap tailored to your business.
STEP 3: Achieve Certification & Compliance - Implement, audit, and succeed.
Certified ISO 13485 Consultant | MDSAP, FDA & Health Canada Experts | 100% Client Success
FAQS
What is the role of a business management consultant?
A business management consultant is an expert who offers specialized guidance to organizations seeking to improve their performance, operations, and overall efficiency. Consultants analyze current processes, identify areas for improvement, and provide strategic recommendations to enhance productivity, achieve growth, and navigate challenges effectively.
When should a company consider hiring a business management consultant?
Companies should consider hiring a business management consultant when they encounter challenges that require specialized expertise, or when they aim to streamline operations, implement strategic changes, or accelerate growth. Consultants are especially valuable during periods of transition, such as entering new markets, undergoing organizational restructuring, or addressing declining performance.
How does a business management consultant tailor their approach to each client's needs?
Business management consultants tailor their approach by first gaining a deep understanding of the client's industry, goals, and challenges. They collaborate closely with the client's team to assess existing processes, gather insights, and identify pain points. With this information, consultants develop customized strategies and action plans that align with the client's unique needs, ensuring a tailored solution that addresses their specific challenges and maximizes opportunities.
OUR TESTIMONIALS
Client's Feedbacks
I am incredibly grateful for the remarkable services provided by [Your Company Name]. As a business owner aiming to revamp our operations, their expertise in business management consulting was invaluable. The team not only comprehensively analyzed our processes but also offered insightful strategies that yielded tangible results. Their personalized approach, attention to detail, and commitment to our success truly set them apart. Thanks to their guidance, we've witnessed a significant increase in efficiency and are now better positioned for sustainable growth. I highly recommend [Your Company Name] to any business looking to navigate complexities with confidence.
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