Medical Devices
Find providers for services for the registration of medical devices, clinical assessments, etc. The list is not exhaustive and no guarantee can be given for the correctness and timeliness of the information provided. Furthermore, please note that this list does not have any recommendatory character.
If you are a provider of services in this area, you have the possibility to register free of charge in this directory.
- Clarification of demarcation issues (medical device – food – drug)
- Compilation of the technical documentation
- Consultation procedure in case of medical devices with pharmacological substances (Class III)
- Gap analysis and interpretation of all relevant product-specific data
- Coordination of required in vitro, in vivo, and/or clinical studies
Michor Consulting and Trade Services GmbH
Schönbrunnerstrasse 238/2/6
1120 Wien
Austria
office@michor-consulting.eu
Michor Consulting can help you:
- Carry out the responsibilities associated with and act as your European Authorized Representative
- Help with CE marking your device. This includes advice during the development phase, helping with the technical file(s) construction and/or review, clarifying the essential requirements, and product classification
- Liaising and your primary contact with Competent Authorities and Notified Bodies
- Register your device(s) with the national Competent Authorities before market entry
- Vigilance reporting
Eisinger Submission Management
Kirchweingarten 14
A-2102 Bisamberg
Austria
kurt@eisingersubmissions.com
- gap analysis technical documentation
- risk assessment
- compilation and maintenance of technical documentation
- Development and licensing out of substance-based medical devices
- Clinical evaluation (MEDDEV 2.7/1), biocompatibility (ISO 10993)
- Implementation of conformity assessment procedure and related support
- Maintenance
- Responsibility as
o Manufacturer (including ISO 13485 quality management)
o Authorised representative for medical devices
o Original equipment manufacturer (OEM) or private label manufacturer (PLM)
o QM officer
o Safety officer - DiapharmKlick: the latest overview of new OTC products in Germany, Austria, Spain, France, the United Kingdom and the US
ProPharma Group GmbH
Siemensdamm 62
13627 Berlin
Telefon: 030/856 06878-0
regulatory.de@xendo.com
ProPharma Group GmbH is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare.
Contact us in any phase of your product's lifecycle if you are looking for a partner in Product Development, Regulatory Affairs, (Pharmaco)vigilance or QA/QC.
- RA management from early preclinical stage to the final steps of maintenance of the license
- Dossier compliation and submission
- Quality Assurance & Risk Management
- Distribution
- Manufacturing
- Quality Management Systems & Quality Control
- GxP & ISO 13485 Compliance
- Product Quality Review & Management Reviews
- Design & execution of Validation Master Plans
- Process & product validation
- Analytical method validation
- Cleaning validation
PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries.
We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.
The PharmaLex Group now has over 1000 employees, with 33 offices in 21 countries and more than 600 satisfied clients worldwide.
- Classification assessment
- Medical device technical documentation creation according to the MDR
- Quality Management System (QMS) updates
- Notified Body interactions
- Post-market continuous support