Overview
Status
Active
Registry date
2020-04-02
Marital property community
Yes
Activity description
Smart Qms Edyta Wierciak-Bożętka supports manufacturers, importers and distributors in bringing medical devices to market. Its services include device qualification and classification, implementation of an EN ISO 13485:2016 quality management system, and preparation of technical documentation in line with MDR 2017/745. It also provides training, audit preparation and risk analysis.
Industry
Offer
- Regulatory consulting for medical devices
- Medical device classification
- Quality management system implementation
- Medical device technical documentation
- Certification audit preparation
- Risk analysis
- Medical device regulatory training
Certifications: ISO 13485
Website technology
- Website
- WordPress
- Elementor
- Analytics and marketing
- Google Analytics
Authorized Representatives
Edyta Wierciak-Bożętka – Owner
Public aid
| Grant date | Purpose | Gross amount | Granting body | |
|---|---|---|---|---|
| Nov 10, 2025 | De minimis aid (in accordance with Commission Regulation 2023/2831) | $445$445 | Prezes Zakładu Ubezpieczeń Społecznych | |
| Dec 17, 2024 | De minimis aid (in accordance with Commission Regulation 2023/2831) | $401$401 | Prezes Zakładu Ubezpieczeń Społecznych |
Competitors
Change history
| Entry date | Operation type | Application number | Application author / Organ entering the change | Change effective date | |
|---|---|---|---|---|---|
2024-02-20 07:12:19 | NIP number confirmed by the Ministry of Finance (6782628720) | Ministerstwo Finansów | 2024-02-20 | ||
2024-02-19 15:08:59 | Change of entry data | 000413098/2024 | Edyta Wierciak-bożętka | 2024-02-19 | |
2021-01-04 09:34:06 | Change of entry data | 000009457/2021 | Edyta Wierciak-bożętka | 2021-01-04 | |
2020-04-14 14:43:20 | REGON number assigned (385876975) | Główny Urząd Statystyczny | 2020-04-14 | ||
2020-04-14 12:11:35 | Change of entry data | 000756276/2020 | Edyta Wierciak-bożętka | 2020-04-14 |