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Czechia - Evaluation consultancy services - Design and implementation of a quality management system and preparation of technical documentation

Original Česko - Hodnotící poradenské služby - Návrh a zavedení postupu systému řízení kvality a příprava technické dokumentace

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  1. Published
  2. Today
  3. Deadline open for 30 days
  4. Awarded pending

Summary

Machine-generated summary

A Czech contracting authority is procuring consultancy services to design, implement and verify a quality management system (with the authority acting as the manufacturer) and to prepare technical documentation for a medical device: a skin covering based on innovative PCL structures. The work must comply with Regulation (EU) 2017/745 (MDR) and its updates, with the goal of ensuring readiness for the conformity assessment procedure and meeting regulatory requirements needed to place the device on the market.

Description

Předmětem veřejné zakázky je návrh, implementace a ověření systému řízení kvality zadavatele zakázky (dále také jako „výrobce“) a příprava technické dokumentace kožního krytu na bázi inovativních PCL struktur (dále také jako „zdravotnický prostředek“) v souladu s požadavky nařízení Evropského parlamentu a Rady (EU) 2017/745 a jeho aktualizacemi (dále jen „MDR“), s cílem zajistit připravenost zadavatele k procesu posouzení shody zdravotnického prostředku a splnění regulatorních požadavků nezbytných pro jeho uvedení na trh.

Official source

Source: TED - Tenders Electronic Daily (Publications Office of the EU)

Always verify details on the official notice.

Last verified against TED - Tenders Electronic Daily (Publications Office of the EU) 1 week ago

More from this buyer

Full buyer profile

2 open tenders right now

This buyer has no award history in this sector yet. Usual winners, Business services - Czechia

Company Wins Total awarded Last win
Trade FIDES, a.s. 11 €40.0M Aug 2026
REMMARK, a.s. 10 €7.0M Aug 2026
EventEx s.r.o. 10 €283,612 Sep 2026
Polypress s.r.o. 9 €1,555 Sep 2026
TISK CENTRUM s.r.o. 7 €170,277 Aug 2026

Based on 681 awards with a linked company profile over the last 2 years.

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Market context

Avg. open tender · Business services
€23,605,020
5,890 open across Europe right now 99% below sector average
Buyer track record on Aperlena
2 notices tracked · 0 awarded

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