Quality & Compliance

01 — The Helsinki Protocol

A strategic partnership, declared in plain language.

How our Finnish team audits the Ankara manufacturing site against the full requirements of MDR (EU) 2017/745.

Helsinki HQ

Strategy & Quality Control

CE technical file update & control
Person Responsible for Regulatory Compliance (PRRC)
Risk management file (ISO 14971)
Post-market surveillance & vigilance reporting
Notified Body & distributor interface

Ankara Hub

Production & Global Shipping

ISO 13485:2016 certified production facility
Injection moulding, assembly and packaging
Validated EO sterilisation
Incoming and finished-goods quality control
Lot release and traceability records
Ex-Works dispatch to global distributors

A device leaves our facilities only after passing four checkpoints.

01

Design Lock

Every device is fixed against a controlled technical file held in Helsinki. Drawings, materials, biocompatibility data and risk analyses cannot be changed at the production line.

Owned by — Helsinki

02

In-Process Audit

Annual scheduled audits and unannounced visits to the Ankara site cover clean-room discipline, calibration records, operator training files and incoming-material traceability.

Owned by — Helsinki QA

03

EO Validation

Every sterilisation lot is released against validated cycle parameters and biological indicator results. No lot ships without a signed Certificate of Sterility.

Owned by — Ankara QC

04

Post-Market Loop

Complaints, field reports and trending data flow back into Helsinki's PMS system within 48 hours — and into a quarterly review with the Ankara production team.

Owned by — Helsinki PMS

02 — MDR & Certification

European safety standards. Verifiable, not asserted.

We do not manufacture in Finland; we do not pretend to. The certificates that authorise the product to be placed on the EU market are real, current, and named below. Available on request to qualified distributors and tender authorities.

Regulatory

CE Certificate

Issued by Notified Body under MDR Annex IX. Lists product families, classification and the manufacturing site.

Quality

ISO 13485:2016

Issued for the Ankara manufacturing site. Covers design transfer, production, sterilisation and post-market.

Per-lot

Certificate of Sterility

Issued for each EO sterilisation lot — cycle parameters, dwell time and biological indicator results.

Per-shipment

Finnish Free Sales Certificate

Signed by the PRRC in Helsinki.

Transparency policy

We name the Motion Medical on every commercial document.

Quotations, invoices, authorization letters and product labels all identify Motion Medical (Helsinki) brand and the Ankara facility as the production site. Distributors, hospital procurement and Notified Bodies see the same information.

03 — Sustainability

Smart Packaging. Less waste at the bedside.

Single-use medical devices generate a real volume of clinical waste. As a Finnish company, we hold ourselves to the Nordic standard on environmental impact — without compromising sterility or shelf life.

−38%

Reduced packaging mass

Across the indeflator and manifold lines, switching to a right-sized carton and thinner recyclable pouch removed more than a third of the packaging weight per unit.

−61%

Less paper in the pouch

Multi-language paper IFUs replaced with a QR-linked eIFU library — per MDR Article 5(3). Distributor-language inserts only where required by national law.

100%

Recyclable secondary

Outer cartons and dividers are FSC-certified mono-material board, printed with soy-based ink. Recyclable in standard hospital and municipal streams.

Roadmap

Per-SKU CO₂e disclosure by 2027

We are working on a per-SKU carbon footprint to be published alongside each Declaration of Conformity from 2027 onwards, aligned with the EU Corporate Sustainability Reporting Directive.