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
OUR TEAM
Our Expert, RAMA ALMALEH
With 8 years of providing QA/RA consulting support to biotech, medtech, and pharma businesses at all levels (startups, small, and medium sized enterprises), my passion is translating the quality and regulatory language to C-level executives, senior management, and technical experts to make quality happen in the most natural and organic way possible.
Let’s talk about expanding market coverage, increasing speed to market, quality management systems (QMS) implementation/improvement, and strategic planning for regulatory compliance.
Competencies include:
ISO 13485:2016 Internal Auditor (TPECS)
ISO 19011:2018 Management Systems Auditing
ISO 14971:2019 Risk Management for Medical Devices
ISO 20417:2021 Medical Devices
ISO 15223-1:2021 Medical Devices
Regulation (EU) 2017/745 - MDR
Health Canada MDR SOR/98-282
U.S. FDA 21 CFR Part 820 & 11 (Medical Devices) - QMSR
Medical Device Single Audit Program (MDSAP)
GS1 Standards (GTIN, GLN, GDSN, Digital Link)
Unique Device Identification (UDI) - EU, FDA, Global
IEC 62304:2006 - Software Life Cycle Processes
ISO 13485 certification for Artificial Intelligence (AI) and Machine Learning (ML) SaMD
Privacy (HIPPA & PIPEDA) and cybersecurity compliance
