our services

What We Offer

Our Services

A group of experienced independent professionals and specialists in each product category, providing strategic regulatory and quality advice.

End-to-end support

Three pillars of expertise

From building a compliant quality system to registering your product across global markets and training your team.

Consulting

Quality management & product standards aligned to your market.

Registration

Thailand, EU MDR, UK MHRA and US FDA submissions.

Training

In-house online or on-site training on the standards you need.

Consulting

Standards & quality management

Consulting on quality management standards and product standards to get your organisation audit-ready.

Quality Management Systems
  • ISO 13485 — Quality Management System for Medical Devices (QMS-MD)
  • MDSAP — a single audit covering Australia, Brazil, Canada, Japan and the United States
  • ISO 9001 — Quality Management System (QMS)
  • ISO 14001 — Environmental Management System (EMS)
  • GHP & HACCP — Good Hygiene Practice and Hazard Analysis and Critical Control Point
  • ISO/IEC 17025 — Competence of Testing and Calibration Laboratories
  • Other standards on request
Registration

Market access across the globe

We prepare your technical documentation and manage submissions in the regions that matter to your business.

Thailand

Registration of medical devices with the Thai FDA.

  • Manufacturer establishment
  • Import establishment
  • Seller's License (specific products)
  • New product registration / Medical Device License — CSDT for class 1/2/3/4

European Union

EU MDR 2017/745 & PPE Regulation 2016/425.

  • MDR Technical Document — Class I, Is/r/m, IIa, IIb and III
  • EU Representative & registration via global partners
  • EU PRRC (Person Responsible for Regulatory Compliance)
  • PPE Technical Document — category 1/2/3
  • QMS for EU MDR & EUDAMED registration (SRN number)
  • EU adverse event reporting

United Kingdom (MHRA)

Great Britain & Northern Ireland markets.

  • UK Responsible Person (UK RP) via global partners
  • MHRA registration via global partners
  • Technical documentation
  • PPE Technical Document (PPE 2016/425 & 2018 enforcement) — category 1/2/3

United States (FDA)

U.S. Food and Drug Administration submissions.

  • FDA Establishment via global partners
  • 510(k) documents and submission
  • Small business certification
  • FDA Medical Device Reporting
  • FDA Warning Letter resolution
Training

In-house training, your way

Upskill your team on the standards that keep you compliant.

  • Choose your format — online, on-site, or both at once
  • Select the standards you need to train on

Not sure where to start?

Tell us about your product and target markets — we'll map out the right regulatory path.

Talk to our team