Clarity first
We make the path visible with short plans, trace links and clean deliverables.
About us
Quality and regulatory outcomes you can rely on
F&R Solutions helps medical device teams move from uncertainty to approvals with clear systems, complete records and confident audits. We focus on practical execution that fits your size and timeline.
Values
How we work with your team
We combine standards knowledge with hands on execution so every hour builds real evidence and momentum.
Evidence that holds
Records and files mapped to standards and markets so audits run smoothly.
Simple systems
Procedures and tools scaled to your team so work stays fast and consistent.
Approach
Practical steps from first call to approval
Expect a focused plan, weekly progress and records that connect design, risk, software and labeling.
How we run the engagement
- Kickoff with scope, milestones and owners
- Gap review against ISO 13485, MDSAP and target markets
- Short sprints that deliver documents and training
- Traceability built across requirements, risk and tests
- Mock audit and evidence polish ahead of inspections
What you will notice
- Decisions captured and files versioned cleanly
- Examples and templates that speed up your team
- Confidence on audit day with clear roles and answers
- Systems sized to your resources and timeline
Leadership
Meet the founder
Rama Almaleh
Founder and Principal Consultant
Rama builds quality systems and documentation that pass audits without added stress. Experience spans ISO 13485 implementations, MDSAP readiness, FDA QMSR and 510(k) support, ISO 14971, SaMD and UDI setup. Clients value Rama's clear plans, complete evidence and coaching that grows capability inside the team.
Focus areas
- ISO 13485 design and implementation
- MDSAP audit prep and CAPA coaching
- FDA QMSR and 510(k) documentation support
- ISO 14971 risk management and files
- SaMD and IEC 62304 documentation
- UDI, GUDID and FURLS setup
Working style
- Weekly deliverables with clear owners
- Templates and examples that save time
- Direct feedback and simple tools
Aligned with global medical device standards
Story
Our path
2022
F&R Solutions founded in Montreal to help device companies build audit ready systems and files.
2022 to today
Support for ISO 13485, MDSAP readiness, FDA documentation, ISO 14971 risk, SaMD and UDI across multiple device types and sizes.
FAQ
Common questions
Do you work with startups and larger companies?
Yes. We scale the engagement to your size. The goal is the same: clear plans, complete evidence and smooth audits.
Can you collaborate with our eQMS or shared drive?
Yes. We work inside your tools and keep ownership clear. We also provide templates where helpful.
Will you prepare us for inspections?
We run mock audits, practice answers and finalize evidence so your team feels confident.
Do you support software and SaMD?
Yes. We align documentation with IEC 62304 and software risk so reviewers can follow the logic quickly.
Ready to talk about your next approval?
Book a quick call to align scope, timeline and outcomes. We will suggest a clear plan and first steps.