Our network
Our network is based on mutuality, trust, and the idea that we can achieve much more together.
We have worked with experienced experts for many years and are happy to recommend them to you as “Trusted Partners.”
These are supplementary services that we do not provide ourselves, such as clinical evaluations, UDI labeling, and usability testing for medical devices and IVDs.
On the other hand, we work with consultants who offer similar services. If we don’t have enough capacity, these consultants can help out!
Dr. Ghazaleh Gouya-Lechner
Gouya Insights GmbH & Co KG
Services:
- Creation of the clinical development plan
- Gap analysis of clinical safety and performance studies up to the CE mark
- Market valuation
- Support for clinical studies
Services & contact details
Gouya Insights’ expertise is in clinical development strategy and planning for innovative biotech and medtech companies and medical device manufacturers. The Gouya Insights team of experts proactively supports the clinical development process – in-time, in-budget and in-quality.
In addition to its advisory role, Gouya Insights also manages clinical development, including the creation of an efficient roadmap for the development program. This includes obtaining scientific recommendations, assembling a clinical-operational team and acting as an interface between sponsors and clinical operations for oversight through to conducting clinical trials and reviews of medical data.
Gouya Insights also provides support with medical writing, i.e. clinical study reports and their publication. The dedicated team has set itself the task of driving innovation for national and international clients in line with the motto “Because we know what we are talking about”.
Our services:
- Creation of the clinical development plan with the definition of the “Target product profile (TPP)”
- Indication selection and definition of the intended purpose
- Gap analysis of clinical safety and performance studies up to the CE mark
- Market valuation (with our network)
- Preparation of the study documents for the clinical “Safety and Performance” studies
- Submission of the study documents to the ethics committee and authorities
- Identification of study centers
- Study team composition
- Overview of the clinical study implementation
- “Medical and scientific writing of all study documents up to the study report, publication, clinical evaluation report and other medical device vigilance in the context of clinical studies
Contact:
Priv.Doz.Dr.Ghazaleh Gouya-Lechner
Gouya Insights GmbH & Co KG
gouya@gouya-insights.com
www.gouya-insights.com
+43 664 2408539
With the code “encotec2022” you receive a 5% discount on all services!
DI Gabriele Ettenberger-Bornberg, BA
OFI Technology & Innovation GmbH
Services:
- Biocompatibility according to ISO 10993
- Chemical characterization
- Degradation studies
- Stability and aging studies (shelf life)
- and much more.
Services & contact details
The assessment of medical and pharmaceutical products is one of the OFI’s core competencies. The range of services includes tests for medicinal products, raw materials and packaging, approval tests for medical devices and the development of innovative hygiene concepts in the area of surface hygiene and air hygiene.
Contact:
Expert for medical devices & hygiene
DI Gabriele Ettenberger-Bornberg, BA
t: +43 1 798 16 01 – 624
m: +43 664 516 2574
gabi.ettenberger@ofi.at
Poppy Abeto Kiesse, MSc
GS1 Austria GmbH
Services:
- UDI labeling
- EUDAMED product registration
- Training courses
Services & contact details
GS1 Austria offers assistance and training for UDI labeling of medical devices and in-vitro diagnostics according to MDR and IVDR. In addition, support with product registration in the European database EUDAMED.
Contact:
Poppy Abeto Kiesse, MSc
Business Development Manager Healthcare
+43 1 505 86 01-101 | abeto@gs1.at
Michael Engler
Benkana Interfaces GmbH & Co KG
Services:
-
Usability engineering / human factors for medical devices
-
for all trades: software, hardware and mechanics.
Services & contact details
- Formative and summative evaluations in accordance with IEC 62366-1, in particular usability tests, also in accordance with FDA requirements in the USA
- Recruitment of users and provision of realistic test environments such as operating theaters, intensive care rooms, etc.
- User research, contextual inquiry, surveys, interviews to determine user needs and usage requirements
- Elicitation and documentation of use scenarios and user interface requirements and incorporation into development
- Use-related risk analysis and transfer of the results to the design input
- Creation of usability engineering files and human factors engineering reports
Contact:
Michael Engler
Senior Consultant, Managing Partner
michael.engler@benkana-interfaces.com
t: +49 201 7493-5001
Use the code “encotec2022” to receive one hour of free advice!
Marie Salin
Salin Consulting
Services:
- Implementation of EU regulations for medical devices and IVDs
- Editing and verification of technical documentation
- Implementation of quality management systems
Services & contact details
“Quality is the product of attention to detail” A. Tenzer
Marie Salin is an experienced Managing Director with many years of experience in the medical device industry. She has knowledge in the fields of medical devices, sales management, biotechnology, management, product development and approval.
Marie Salin is an expert on the European market and its medical regulations and speaks fluent German, French and English.
Services:
- Implementation of EU regulations for medical devices and IVDs
- Editing and verification of technical documentation
- Implementation of quality management systems
- Additional services: Risk, audits, workshops, …
Contact:
Marie Salin
T: +43 676 6123 886
msa@salin-consulting.com
With the code “encotec2022” you receive a 5% discount on all services!
Services & contact details
Specialist for eQMS:
Günter Rodenkirchen has been working as a consultant for the digitalization of QM systems since 2013 and as a product manager for QMS software since 2016.
Although his focus is on so-called “regulated companies”, i.e. pharmaceutical manufacturers and manufacturers in the medical technology sector, his customers also include “traditional” industrial companies that want to support their QMS through the use of software following successful ISO 9001 certification.
It is not just about the actual introduction of QMS software, but also about supporting companies in preparing their organization for the use of the software.
Contact:
Günter Rodenkirchen
guenter.rodenkirchen@gpr-consult.de
Use the code “encotec2022” to receive a 5% discount on all services!
Dr. Beate Panosch, LL.M.
Focus Dr. Panosch KG
Services:
- Clinical evaluation and study planning
- Clinical studies/non-interventional studies
- Training courses
Services & contact details
Services:
- Medical devices: Clinical Evaluation according to MEDDEV 2.7/1 revision 4 [Clinical Evaluation Plan, Clinical Evaluation Report, Literature Search Report], risk analyses/risk assessments
- Clinical studies/non-interventional studies
- Support in planning, preparation and revision of documents (study protocols, CRFs, patient information and informed consent forms), monitoring, data management, analysis, presentation of results (final study report, publication, summaries)
- Training courses
Contact:
Dr. Beate Panosch, LL.M.
Focus Dr. Panosch KG
T: +43 664 4503897
service@e-health.at
DI Melanie Baumgartner, BSc
R’n’B Consulting GmbH
Services:
- Support with MDR and IVDR implementation
- GAP analysis for existing documents
- Supporting the development of technical documentation
- Individual workshops
- Medical device consultant training
Services & contact details
From the initial idea to clinical evaluation and market surveillance: RnB Consulting’s mission is to provide support in the field of medical technology!
Services:
- Support with MDR and IVDR implementation
- GAP analysis for existing documents
- Supporting the development of technical documentation
- Individual workshops
- Medical device consultant training
Contact:
DI Melanie Baumgartner, BSc
R’n’B Consulting GmbH
T: +43 677 6122 89 67
office@rnb-consulting.at
With the code “encotec2022” you will receive a 5% discount on all services!
Lydia Langkammer
PRSG Pharmaceutical and Regulatory Services GmbH
Services:
- Approval of medical devices
- Import and marketing of medical devices and in-vitro diagnostics
- Marketing authorization and life cycle management of medicinal products
- Legally compliant marketing of food supplements and FSMPs
Services & contact details
PRSG – Pharmaceutical and Regulatory Services GmbH is a company that offers comprehensive services in the field of regulatory affairs as a one-stop store.
PRSG’s services include solutions for regulatory issues in the following areas:
- Approval of medical devices
- Import and marketing of medical devices and in-vitro diagnostics
- Marketing authorization and life cycle management of medicinal products
- Legally compliant marketing of food supplements and FSMPs
Contact:
Lydia Langkammer
PRSG Pharmaceutical and Regulatory Services GmbH
lydia.langkammer@prsg.at
With the code “encotec2022” you will receive a 5% discount on all services!
Thomas van den Oever
Qualitätsberatung e.U.
Services:
- Quality management systems for manufacturers and suppliers in the medical technology sector
- Audit support
- Lean management
- Training courses
Services & contact details
My services include the introduction and optimization of QM systems for manufacturers and suppliers in the field of medical technology with the following focal points:
- Internal audits, supplier audits, due diligence and GAP analyses against 9001, 13485, MDR, IVDR, MDSAP, FDA and customer requirements
- Implementation of remediation projects
- Preparing for and accompanying external audits/inspections
- Interim Head of Production and QM
- Support for the closure or transfer of locations in a regulated environment
- Lean management in a regulated environment
Contact details:
Thomas van den Oever e.U.
Phone: +43 664 8317672
office@vandenoever.at
With the code “encotec2022” you receive a 5% discount on all services!
Dr. MMag. Markus Speiser
Speiser.Regulatory
The medical device market is highly regulated and requires compliance with numerous regulatory requirements. As a doctor of law, trained business economist, project manager and data protection officer, I support economic players in this very exciting environment in order to be able to place medical devices on the market.
My services include:
- Consulting in the field of Software as a Medical Device
- Support with MDR implementation
- Regulatory compliance for quality management systems
- Internal audits according to MDR, ISO:13485
Services & contact details
Services:
- Consulting in the field of Software as a Medical Device
- Support with MDR implementation
- Regulatory compliance for quality management systems
- Internal audits according to MDR, ISO:13485
Contact:
Dr. Markus Speiser
Speiser.Regulatory
Lenerweg 5 | 6067 Absam | Austria
Mobile: +43 677 61 02 92 18
DI(FH) Dr. Michael Ring
mring-Consulting
Services:
- Planning and conducting clinical evaluations of medical devices
- Coordination of clinical studies
- Systematic literature searches and the planning of clinical trials
Services & contact details
Services:
- Planning and conducting clinical evaluations of medical devices
- Systematic literature research
- Planning clinical trials
Contact:
DI(FH) Dr. Michael Ring
Medical Devices – Consulting
T: +43 677 990 12 996
Email: office@mring-consulting.at
Michael Zitterl
Management consultancy Mag. Zitterl
Services:
- Management systems for quality, environment and safety
- Paperless documentation (online business models with PROMOL)
- CE marking: medical devices, machinery, low voltage, EMC
Services & contact details
Services:
- Management systems for quality, environment and safety
- Paperless documentation (online business models with PROMOL)
- Mission statement development, corporate policy
- CE marking: medical devices, machinery, low voltage, EMC
- Preventive services: workplace evaluation, safety experts, occupational medicine
- The further development of your management system in the direction of TQM (AFQM, EFQM, ISO 9004)
- Development of autonomous, independent and team-oriented employees
- Analysis and optimization of project workflows and business processes: Development and description of processes, coaching during implementation, measurement of target achievement and training of your employees
Contact:
Michael Zitterl
Management consultancy
T: +43 660 1002769
zitterl@zitterl.com
With the code “encotec2022” you receive a 5% discount on all services!
