Quality, registrations and support

Documentation in order before the first sale.

Registration, sourcing, traceability and instructions for use, organized by lot. The hospital buys safety before it buys an implant, and this page exists so you arrive with that part already settled.

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Quality policy

Here, quality is a condition of entry, not a sales argument.

An implant enters the operating room once. There is no second chance to correct questionable sourcing, incomplete documentation or an untraceable lot. That is why Sinapse treats regulatory clearance and documentation as a prerequisite for a solution to exist in the portfolio, not as a selling point to be communicated later.

In practice, that means selecting manufacturers with auditable processes, keeping regulatory clearance active, organizing technical documentation by line and by lot, and delivering it ready for the distributor to present to the hospital. When the clinical staff asks, the answer is already in hand.

The chain of trust

From manufacturer to OR, in three stages.

Each stage answers a different question from the hospital. Together, they are what lets you enter a negotiation without relying on a verbal promise.

Stage 01

Origin and regulatory clearance

Before any commercial discussion: where it comes from, who manufactures it and whether it is cleared for sale in Brazil.

  • ManufacturersAn auditable production process and a verifiable track record.
  • SourcingKnown and documented origin for every solution.
  • Regulatory clearanceRegulatory status kept active and monitored, not obtained once.
  • ANVISA registrationsThe corresponding registration available on request.
  • CertificationsManufacturer certifications organized and accessible.
Stage 02

Tracking and documentation

What the hospital asks for at purchase and after surgery, gathered by line and by lot so you can present it without chasing it down.

  • TraceabilityLot identification, from inventory through to the procedure.
  • Instructions for useIFU in the current version, in the required language, by family.
  • Technical documentationDossier and product information gathered by line.
Stage 03

Use, storage and surveillance

What sustains safety after the material leaves our hands and enters your operation.

  • StorageGuidance to preserve integrity and shelf life.
  • Post-market surveillanceA defined channel and procedure for reporting adverse events.
Compliance

A clean relationship protects both sides.

Distributing medical devices involves the hospital, the clinical staff and the payer. Any shortcut falls back on the person at the front line, and that is you. Sinapse keeps clear rules and an open channel precisely so that the conversation never has to be rebuilt later.

Commercial conduct

Rules agreed in writing and kept, with no side deals and no term that cannot fit in a document.

Ethics channel

A direct path to report improper conduct, with investigation and feedback. Open to your team as well.

Distributor support

Support does not end when the invoice is issued.

Training, sales material, technical support on the case and after-sales. What sustains your operation once the order is already in.

  • Technical support by line
  • Training for your team
  • Supporting sales materials
  • After-sales follow-up
  • Storage guidance
  • Documentation support
Technical documentation organized by line
Let's talk

Do you need a specific document?

If the hospital asked for a registration, an IFU or the dossier for a line, talk to us and we will organize what you need to present.

Request documentation See the lines
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