BASIER SERVICES

Medical Device Consulting from Requirements to Market

Four connected pillars for regulatory affairs, quality systems, technical documentation, and market access, with clear scopes and actionable outputs.

REGULATORY PILLAR

Regulatory affairs & licensing

We turn device status, reference markets, and available evidence into a clear route showing decisions, requirements, and gaps before submission.

Medical-device registration and MDMA supportPathway and classification assessment

Who is this for?

QUALITY PILLAR

We build the system around the organization’s real processes and turn requirements into responsibilities, documents, records, and closure controls.

ISO 13485 QMS implementationGap assessment and audit readiness

Who is this for?

EVIDENCE PILLAR

We review the dossier as a connected evidence chain, not a document folder, and identify where evidence is absent, weak, or inconsistent.

Technical file review and gap assessmentProduct compliance and evidence traceability

Who is this for?

MARKET PILLAR

We connect regulatory status, commercial data, supplier requirements, and tender inputs so gaps are visible before market or bid commitment.

Saudi market-entry readinessNUPCO and tender readiness

Who is this for?

NEXT STEP

Sources describe the general framework. Current versions and case-specific requirements must be checked before a regulatory or commercial decision.