Basier CompanyMedical Device Regulatory Consulting
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Medical device regulatory consulting

A clearer regulatory path to the Saudi medical device market

Basier provides structured regulatory pathways, technical-documentation and quality-system support, and market-aligned guidance for medical-device manufacturers, importers, and distributors navigating Saudi requirements.

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  • Saudi market focus
  • Verifiable official sources
  • Reviewable deliverables
About Basier

Regulatory expertise connecting decisions, evidence, and execution

Basier is a Saudi medical-device consultancy. We work with regulatory, quality, and leadership teams to turn scattered requirements into a clear scope, accountable actions, and reviewable outputs.

About Basier
What we do

Four pillars, each answering a different question

Work can begin in one pillar while licensing, quality, technical evidence, and commercial readiness remain connected but distinct.

01

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?
  • Manufacturers planning Saudi market entry
  • Teams needing classification and pathway clarity
  • Importers assessing readiness before commitment
02

QMS & ISO 13485

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?
  • Organizations building a first QMS
  • Organizations restructuring an existing system
  • Teams preparing for an external audit or certification
03

Technical documentation & product compliance

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?
  • Manufacturers building a new dossier
  • Teams seeking an independent review of an existing file
  • Products needing change-impact review across evidence
04

Market access & tender readiness

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?
  • Manufacturers assessing Saudi market-entry readiness
  • Suppliers reviewing records before a tender
  • Teams separating licensing from commercial readiness
Who we support

Focused support for each organization and team role

Manufacturers

Clarify the pathway, technical dossier, and QMS before market commitment.

Importers and distributors

Test product, establishment, channel, and local readiness.

Healthcare and technology organizations

Understand regulatory boundaries and the evidence the solution needs.

Regulatory and quality teams

Turn gaps into decisions, ownership, and closure evidence.

How we work

From the actual situation to a reviewable output

  1. 01

    Understand the situation

    Device, intended purpose, market, and decision needed.

  2. 02

    Establish requirements

    Current sources and each authority or route boundary.

  3. 03

    Test the evidence

    What exists, is missing, conflicts, or needs verification.

  4. 04

    Deliver the output

    A roadmap, register, or plan with clear closure criteria.

Basier Insights

Regulatory knowledge you can use

Focused guidance built from official sources, with clear review dates and practical implications for medical-device teams.

Basier engagements

Work cases

Engagements delivered by Basier, showing the device category, challenge, work completed, and output while keeping company and brand names confidential.

Regulatory affairs and licensing

Defining the regulatory route for a multi-model diagnostic-device family

Device or product type
An in-vitro diagnostic family sharing a common platform across models with different configurations and accessories.
Challenge
The family scope and pathway-relevant differences were not clearly defined, leaving evidence allocation and preparation ownership unclear.
Basier’s work
Basier structured the product facts, intended purpose, variants, and reference markets, then connected each decision to its source and required information.
Output
A pathway memo, document map, and open-decision register.
QMS and ISO 13485

An ISO 13485 operating roadmap for a medical-device distributor

Device or product type
A general medical-device portfolio handled through importing and distribution operations.
Challenge
Procedures were disconnected from process ownership and operating evidence, obscuring priorities and proof of implementation.
Basier’s work
Basier reviewed QMS scope, processes, ownership, documents, and records, then prioritized gaps by risk and dependency.
Output
A process map, document matrix, gap register, and closure plan.
Technical documentation and product compliance

Rebuilding evidence traceability for a generic therapeutic-device dossier

Device or product type
A generic therapeutic device with a dossier covering risk management, verification reports, and labelling.
Challenge
Document presence did not show that design requirements and risk controls were covered by traceable evidence and acceptance criteria.
Basier’s work
Basier tested the trace across risks, controls, design requirements, verification protocols and results, and labelling.
Output
A traceability matrix and gap register separating absence, insufficiency, and inconsistency.
Market access and tender readiness

Separating authorization from tender readiness for a generic monitoring device

Device or product type
A generic monitoring device entering the Saudi market through an importer and healthcare-supply channel.
Challenge
Regulatory status was being treated as if it automatically covered supplier, product, catalogue, and procurement-opportunity data.
Basier’s work
Basier compared product status, supplier and channel data, item description, and available participation requirements, then clarified each party’s responsibility.
Output
A readiness assessment, gap register, and verification list before a participation decision.
Next step

Discuss your need in a focused regulatory call

Choose a suitable time to discuss the device, its current status, and the decision ahead—without sending confidential files before scope is agreed.

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