MedtechVault, secure document exchange platform for
Data sharing with Economic Operators
Efficient conformity assessments
Your OEM/OBL business under MDR/IVDR
Earning trust from your [critical] suppliers
- Digital platform for efficient & structured communication between Economic Operators & Notified Bodies
- Digital platform for secure data exchange under MDR/IVDR
- State of the art security (ISO/IEC 27001:2015) and security features
- All data physically stored on servers located in Germany
- Seamless add-on to your ERP & QMS
- No capital expenditures, ready immediately
MedtechVault is the ideal solution for your needs for secure and efficient document and data exchange in the medical device and in-vitro diagnostics industry.
MedtechVault enables secure communication between the economic operators like legal manufacturers, [critical] suppliers, authorized representatives, distributors, importers as well as notified bodies for all your corporate and medical technology related information.
MedtechVault allows continuation of the OEM/OBL Business under MDR/IVDR.
- Conformity assessment of the technical documentation with your notified body
- Remote audit with your notified body and/or critical suppliers
- Secure information exchange with Economic Operators and/or your Authorized Representative
- Smart and MDR/IVDR compliant solution for confidentiality issues between supplier and legal manufacturer (OEM/OBL business)
- Trust building with your supplier(s)
- Retention of your supplier(s)
Time, resources & cost savings
- Single file (location) for different registrations, submissions, audits
- Expandable to other regulatory authorities outside CE region
- Integrated Q&A
- Easy to use & efficient
MDR / IVDR compliance
- Technical Documentation up-to date and available at all times
- Full Traceability & Archiving over entire product lifecycle
- Compliant with notified body requirements
Who we are
Arik Zucker pursued a successful international job career within global medtech companies, covering Quality Management, Regulatory Affairs & all aspects from product development to product management. Arik Zucker has also worked in strategic business consulting at The Boston Consulting Group. Arik Zucker graduated from the ETH Zurich with a Master’s degree in Physics.
Dr. Armin W. Mäder
Dr. Armin Mäder is a serial life science entrepreneur. He held senior positions in biotech and medtech companies such as Institut Straumann AG, AC Immune SA and Neurotune AG. Armin Mäder started his professional career in the UBS Investment Bank. Armin Mäder holds an M.B.A. with a focus in finance from IMD in Lausanne. He graduated from the ETH Zurich with a Master’s degree in Natural Sciences and holds a PhD in Molecular Biology and Biophysics from ETH Zurich.