Consulting for EU MDR certification, ISO 13485 QMS and EU market entry for medical device manufacturers
Zechmeister Strategic Solutions GmbH
Klagenfurt am Wörthersee (AT)New on Amplifa
About Strategic Solutions for MedTech
Zechmeister Strategic Solutions GmbH is a management consultancy specialised in the medical device industry, based in Klagenfurt am Wörthersee. The company supports international MedTech manufacturers with EU market entry as well as Austrian startups with their first CE certification under the EU MDR. The service portfolio includes gap analyses, setup and upgrade of quality management systems according to ISO 13485, technical documentation (MDR Technical File, Annex II/III), risk management according to ISO 14971, biocompatibility strategies according to ISO 10993, clinical evaluations and studies, EMC and safety testing coordination, Notified Body support as well as services as Authorised Representative including EUDAMED registration. In addition, hardware and firmware development, production setup in Europe, regulatory training and funding optimisation (FFG, aws) are offered. Founder Dipl. Ing. Tibor Zajki-Zechmeister is an accredited Lead Auditor at a Notified Body and has guided more than 50 companies through MDR certification. The company works exclusively with business customers (B2B) in German and English.
- Site
- Klagenfurt am Wörthersee
- Processes
- EU MDR certification consulting, QMS implementation & upgrade (ISO 13485), Technical documentation (MDR Technical File, Annex II/III), Risk management according to ISO 14971, Biocompatibility strategy (ISO 10993), Clinical evaluation / CER creation, Clinical trial (study execution), EMC testing & electrical safety testing (test coordination)
- Materials
- EU MDR certification consulting, QMS implementation & upgrade, Risk management, Biocompatibility, Notified Body support, Authorised Representative, EMC & safety testing, Hardware & firmware development
- Certificates
- Accredited NB Lead Auditor (QMS & Technical Documentation), ISO 13485 consulting/QMS setup
- Industries
- MedTech / Medical devices, Diagnostics, Startups in the medical device sector
- 01
Strategic assessment & gap analysis
- 02
Documentation & QMS upgrade (ISO 13485)
- 03
Testing & clinical evidence (ISO 10993, CER, studies, EMC)
- 04
Notified Body process (submission, mock audits)
- 05
Market entry (CE marking, EUDAMED, Authorised Representative, PMS)
Services & Standards
EU MDR certification consulting
Support from gap analysis to CE marking for international companies and startups.
QMS implementation & upgrade
Setup or adaptation of quality management systems for the EU MDR including internal audits.
Risk management
Creation and maintenance of the risk management file as part of the technical documentation.
Biocompatibility
Biological evaluation plan, test planning, toxicological assessment and test report.
Notified Body support
Selection, application preparation, mock audits and non-conformity management up to the certificate.
Authorised Representative
Legal EU representation for non-EU manufacturers including EUDAMED registration, vigilance and PMS.
EMC & safety testing
Test coordination for EMC and electrical safety requirements to avoid re-testing.
Hardware & firmware development
Development support aligned with design controls and technical documentation.
Locations
Klagenfurt am Wörthersee
ATHeadquarters / Office
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| EU MDR certification consultingEngineering | – | – | – | – | – |
| QMS implementation & upgrade (ISO 13485)Engineering | – | – | – | – | – |
| Technical documentation (MDR Technical File, Annex II/III)Engineering | – | – | – | – | – |
| Risk management according to ISO 14971Engineering | – | – | – | – | – |
| Biocompatibility strategy (ISO 10993)Testing | – | – | – | – | – |
| Clinical evaluation / CER creationTesting | – | – | – | – | – |
| Clinical trial (study execution)Testing | – | – | – | – | – |
| EMC testing & electrical safety testing (test coordination)Testing | – | – | – | – | – |
| Notified Body support / audit preparation (mock audits)Engineering | – | – | – | – | – |
| Authorised Representative services (EUDAMED registration, vigilance, PMS)Engineering | – | – | – | – | – |
| Hardware & firmware developmentEngineering | – | – | – | – | – |
| Local manufacturing (production setup, supplier qualification, process validation)Engineering | – | – | – | – | – |
| Regulatory training (MDR, ISO 13485, internal auditor, PMS/vigilance)Engineering | – | – | – | – | – |
Additional services
Reference customers
Qualification & Compliance
The founder is an accredited Lead Auditor at a Notified Body for QMS and technical documentation and prepares customers for Notified Body audits. The consulting follows the EU MDR, ISO 13485, ISO 14971 and ISO 10993.
| Evidence | Klagenfurt am Wörthersee |
|---|---|
| Accredited NB Lead Auditor (QMS & Technical Documentation) | |
| ISO 13485 consulting/QMS setup |
History
- 2010
Tibor Zechmeister starts in the MedTech sector
- 2011
Founding of the first MedTech company
- 2022
Certification as Lead Auditor at a Notified Body
- 2025
50+ companies guided through MDR certification