ISO 13485 certification readiness
A structured gap assessment with prioritized actions, documentation, and training aligned to audit expectations.
MedTech Regulatory Compliance
Keeping MedTech Compliance Simple
ISO 13485 • MDSAP • EU MDR • US FDA QMSR • Health Canada MDR • SaMD
Trusted across global medical-device standards & regulators
Consultant Guided Quality Excellence
Compliance made practical with clear deliverables that support certification
From ISO 13485 and MDSAP to FDA 510(k) and EU MDR, we translate requirements into a structured execution plan your team can run with confidence.
MDSAP audit confidence
Mock audits and CAPA coaching built to mirror real inspection flow so your team is ready on the day.
SaMD and IEC 62304
Lifecycle documentation, software risk, and traceability that align evidence with regulator expectations.
Faster market entry
510(k), MDEL, and EU MDR strategy designed to reduce rework and accelerate approvals.
How it works
From gap to certification - step by step
A clear, repeatable path that aligns ISO 13485, MDSAP, FDA 510(k) and EU MDR so your team can execute with confidence.
1. Assess
Targeted gap assessment across ISO 13485, MDSAP and FDA with a prioritized action plan.
2. Implement
SOPs, training and ISO 14971 risk files tailored to your device and market strategy.
3. Audit & Approvals
Mock audit, evidence polish and submission support for inspections, 510(k) and MDEL.
Services
Services at a glance
Choose what you need. We tailor the engagement to your device, market, and timeline.
ISO 13485 certification support
QMS design, SOP pack, training plan, and audit readiness from day one.
MDSAP audit readiness
Mock audits and CAPA coaching that reflect real inspections with zero surprises.
FDA QSR and 510(k)
Submission strategy, documentation mapping, and responses to reviewer questions.
Risk management ISO 14971
Risk files, control measures, and traceability aligned to your device and use cases.
SaMD and IEC 62304
Lifecycle documentation and software risk that meet SaMD expectations.
UDI, GUDID, and FURLS
Device identifiers and submissions set up correctly for each market.
About
Meet your MedTech compliance partner
I help medical device teams achieve ISO 13485, MDSAP, FDA 510(k), and EU MDR with clear plans and audit-ready evidence.
Rama Almaleh is a QA and RA consultant with more than 10 years of hands-on experience across biotech, MedTech, and pharma. She focuses on practical QMS design, inspector-style mock audits, and documentation your team can maintain.
ISO 13485 Internal Auditor
ISO 19011 Management Systems Auditing
ISO 14971 Risk Management
FDA QSR and 510(k)
EU MDR
MDSAP
GS1 UDI and GUDID
IEC 62304 SaMD