MedtechVault, secure document exchange platform for

  • Remote audits
  • Data sharing with Economic Operators
  • Efficient conformity assessments
  • Your OEM/OBL business under MDR/IVDR
  • Earning trust from your [critical] suppliers

About
MedtechVault

  • 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
  • Personalized support and consulting by experienced professionals

Your benefits

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.

This is the personalized and industry-tailored solution that you have been looking for. Developed by experts for the industry, paired with support and consulting if needed.

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.

Versatility

  • 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

Supplier Confidentiality

  • 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, tailor made support

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

Feature Stories

Checklist for a Secure Remote Audit

Recommended measures for your video conferencing system Use a registered account (not a free service) Make sure of latest software version Protect all meetings with a password Chose a service with a “waiting room” option, check-in all participants prior to start & banish intruders After start block meeting to prevent further access Restrict access rights to protect screen sharing against...

Remote Audits for Medical Device Manufacturers: protect your sensitive Data & Trade Secrets!

Medical device manufacturers must grant access of highly sensitive data and information to Notified Bodies during Remote Audits. Although such information is never meant to leave the manufacturer’s site it is often shared via common cloud services, especially in times of travel restrictions. How can transfer of sensitive information be established to securely conduct a Remote Audit? by Arik...

Need help with your European Authorized Representative?

How do you secure your sensitive & confidential Technical Documentation while giving it out of hands, e.g. to your European Authorized Representative? Here’s the solution: MedtechVault is a highly secure platform to make your Technical Documentation available to your Authorized Representative (AR) and other Economic Operators while providing best possible protection. Also, it enables proven...

Accelerating the Conformity Assessment process

Curious about how MedtechVault can help accelerating your Conformity Assessment process? Read a blog from Aligned AG for an article that also points out how to deal with the tricky OEM / Legal Manufacturer relationship under MDR! Link to article.    

OEM business model under MDR – proposal for solution

The Johner Institute recently published an article about the OEM business model under MDR. A solution where an intermediary would provide a repository of the documentation was suggested. See the full article in their blog.

News

Virtual Audits in Medtech – a Call for Action

In a recent Webinar, the role of virtual audits was assessed. Virtual or remote audits are currently one of the most relevant topics within the Medical Device Industry, especially in times of the...

MDR introduction postponed to May 26, 2021

(Swiss Medtech) On 17 April 2020, the EU Parliament adopted a proposal to postpone the date of application of the Medical Devices Regulation (MDR) by one year to the 26 May 2021. The regulation...

Remote Audits allowed by EU Commission

See MDCG guidance how notified bodies can run audits while quarantine / travel restrictions prohibit site visits. The document clearly points out to use "the most advanced available Information and...

MDR introduction delayed in the light of the COVID-19 pandemic?

German medtech trade group BVMed called for a postponement until the end of the coronavirus crisis, pointing to the effect of the outbreak on already stretched notified bodies to make its case. And...

MedtechVault at the MDR Support Panel Event in Berne

The MDR Support Panel provided some insights on the implementation of MDR with a special emphasis on the technical documentation with presentations by Bassil Akra (TÜV SÜD), Michael Maier (Medidee)...

MDR – 4-year transitional period for certain Class I devices

The EU Parliament officially accepted the 2nd MDR corrigendum. As no request for a vote had been made on Tuesday 17 December, the text was deemed adopted. This concerns Class I products that were...

Four-year transitional period until 2024

MDR: some Class I medical devices will get a four-year transitional period until 2024 as per 2nd Corrigendum issued by European Council. The Corrigendum on MDR (Nov. 25, 2019) states: "By way of...

Update by Swiss Medtech regarding the MRA

From Swiss Medtech: The Medical Device Regulation (MDR) comes into effect in less than half a year. Legal uncertainty regarding the status of Swiss medical devices after 26 May 2020 remains...

Implementation of Eudamed for MDR delayed by 2 years

The European Commission has confirmed that the introduction of Eudamed for MDR will be delayed by 2 years to May 2022 and will be done together with the Eudamed introduction for IVDR. It should be...

Dekra Certification for IVDR

After having obtained designation for MDR as third Notified Body (after BSI Assurance UK Ltd and TÜV SÜD Product Service GmbH), DEKRA is now the first IVDR Notified Body. Congratulations! ...

Who we are

Arik Zucker

Arik Zucker

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 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.

Interested?
Please get in touch with us.

 

 

 

MedtechVault
METEVA Group AG
Technoparkstrasse 1
CH-8005 Zürich
Switzerland

 

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Digital platform for secure data exchange under MDR/IVDR