February 04 2020

Ripple effects of all sorts is felt on many levels throughout the industry due to the strained European MDR situation. The bottom line is simply more work for everybody. As medical device players scramble to get compliant in time, the convoluted situation has ignited creativeness among digital solution providers. New propositions emerge on how to carry out the increased workload in the most efficient manner possible. We cenrtainly try to be one of these providers but there are plenty of other exciting companies with fantastic ideas.

One such solution provider is MedtechVault in Switzerland, a company that launched its digitization product in 2019 to target some of the complexities that emerge out of MDR. We had the opportunity to meet with Mr. Arik Zucker, co-founder of MedtechVault, and got the chance to ask him more about MedtechVault.

Mr. Zucker, what is the story behind the creation of MedtechVault?

"As a medical device entrepreneur, I experienced the ordeal of taking a medical device to the market under the MDD regime and I was taken aback by the amount of menial tasks, manual ways and bureaucratic hold-ups that characterized the process. Like many before me, I learnt a lot during this time. However, the opportunities to accelerate the process using modern technology became very apparent.

"We chose to target the conformity assessment process. Imagine that your technical documentation is finally completed and you can now submit it to the notified body for assessment. If you are anything like myself, you have a strong feeling of completion and relief at this point. You feel that most of the work is done and you are very close to finally access the market.

Well, lo and behold, now starts a long process of email ping-pong between yourself and the assessor about the locating particular pieces of information in the documentation, about not having access to the right documents and general confusion. Documents are sent back and forth, questions are asked and asked again, long chains of emails are exchanged and there is an increasing feeling of being stuck in a bureaucratic quagmire."

"With MedtechVault, we set out to create a digital collaboration platform for structured and secure communication between the Notified Bodies and the medical device manufacturer. With our current approach, estimations show an (up to) 70% work reduction while simultaneously accelerating the assessment process. Involved stakeholders include the Legal Manufacturer, Critical Suppliers & Notified Bodies / Regulatory Authorities. Of course, any other Economic Operators can be included as well."

MedTechVault

With the new playing rules of MDR, I assume that MedtechVault not only concerns manufacturers?

"Exactly. As you know, MDR has had massive implications on the OEM / Legal Manufacturer relationship. For example: it is no longer sufficient to refer to the original OEM manufacturer's certificates within one’s own conformity assessment. Instead, the Legal Manufacturer now has to assess the documentation or make an assessment of the conformity of the product.

Furthermore, the Legal Manufacturer has to demonstrate the assessment to their NB and therefore needs to be prepared to submit the OEM's part of the technical documentation - including parts containing the OEM's trade secrets!

This constitutes a precarious dilemma since there is an obvious risk in handing over trade secrets to a party (i.e. the Legal Manufacturer) with an obvious incentive to make use of such secrets."

Consequently, MedtechVault is built to handle this situation. Information access can be strictly regulated and access to applicable documents can be handed out on a need-to-know basis. In this way, the OEM's documentation is available to the NB within the scope of the assessment of the Legal Manufacturer but cannot be accessed by the Legal Manufacturer himself."

So what are the technical prerequisites required to start working with MedtechVault?

"Next to none. You upload your technical documentation onto a hosted digital platform. The system is compatible with documents of any file format. MedtechVault operates as a seamless add-on to any ERP and QMS already in place. The data is stored on highly secured servers located here in Europe. This means zero capital expenditures, zero maintenance and zero IT overhead for our customers."

In your opinion, who will benefit from MedtechVault?

"Anybody subjected to a conformity assessment process will benefit from MedtechVault, especially Legal Manufacturers working with OEM manufacturers. MedtechVault will speed up the communication, free up valuable QARA resources and accelerate your assessment procedure."

January 07 2020

If you are interested in reducing your Med Tech documentation workload, then sign up for our Best Practices in Development Documentation workshop in Schlieren Thursday, 16 January 2020 at 14.00!

Together with eight other Med Tech Development Service Companies, we are providing Best Practice Insights in medical device development under the umbrella of the Regulatory Journey, an event hosted and organized by the Healthtech Cluster.

A packed program from 14:00 to 20:00 will provide you with a selection of 30 minutes workshops and talks, hosted by Med Tech Experts.

If you are a start up and you have questions about how to proceed with your development, this is the place where to get your answers!

And it's free!

man wearing

See you there!

For more info and sign up, follow this link.

Location: Startup Space by IFJ Institut für Jungunternehmen AG Wiesenstrasse 5, 8952 Schlieren

 

April 07 2019

 

Sharpen your Skills 2019

May 21st, 2019 | HWZ University, 3 minutes from Zürich Main Station


armchairs blur business 296883 3

Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2019.

We have called on a group of experienced industry expert to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to see you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

REGISTER NOW!


Key Learning Objectives

The way to MDR: real world experience

The MDR transition window is closing. Manufacturers, Notified Bodies, and Distributors are working vehemently to reach the opposite shore in one piece.
An excerpt of the experience of adapting to these new requirements, including hints and best practice are presented in this session.

Presented by: Hansjörg Riedwyl, CEO, ISS AG

Hidden cost drivers in clinical investigations - the importance of strategy

Market access and approval is more dependent than ever on clinical data. Getting your clinical trial design right, in time and within budget, is one of the most important steps.
This session focuses on the importance of collaboration with regulatory and clinical operations experts to minimize the risk for delays as well as the costs.

Presented by: Carin Nilsson, Partner, Confinis CPM

Computer System Validation CSV – between ZERO and HERO

How to best handle the conflicting expectations from Management, IT, Quality Department and (last but not least) the Auditor?
Gerhard Dariz provides deep, real-world insights from corporate practice and show possible strategies to survive this area of tension.

Presented by: Gerhard Dariz, CEO, Inmedis GmbH

Clinical Evaluation and Post Market Clinical Follow-Up under MDR

MDR introduces important changes in expectations on how to demonstrate device safety and performance prior to market access.
This session provides an overview and hands-on examples of the Clinical Evaluation and Post-Market Clinical Follow-Up processes under the MDR.

Presented by: Dr. Autumn Lang, CEO, Confinis CPM

Automated Design Control Documentation

Machine Learning. Digitalization. The future holds a promise of machines performing more and more of our daily tasks. However, many of us are still putting Design Control Documentation together character by character. Can the Design Control Documentation be automated? What would that look like? What are the limitations?

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG


Time and Place

  • Date: Tuesday May 21st
  • Time: 08:15 - 13:30
  • Place: HWZ University, Zürich

Presentations are held in German. Slides written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel and other industry professionals engaged in medical device development.

Registration

We are looking forward to see you at this seminar!

Registration Fee: 125 CHF

30% early bird discount for registration before May 1st.

REGISTER NOW!


Location

Address: HWZ Hochschule für Wirtschaft Zürich, Lagerstrasse 5, Zürich

HWSMap

 

About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 HTCS

April 01 2018

 

Sharpen your Skills 2018

May 17th, 2018 | HWZ University, 3 minutes from Zürich Main Station

Skills

Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2018.

We have called on a group of experienced industry expert to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to see you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.


Key Learning Objectives

Medical Device IT Security

Live hacking session, an introduction to the regulatory requirements and hands-on tips for developers of medical devices - by Prof. Dr. Christian Johner, CEO, Johner Institute

Implementing GDPR at Polar

Learn more about how Polar implemented one of the most important regulatory changes in 2018. If you haven't started yet, get the do's and don's from Niclas Granqvist, Director Apps & Electronics, Polar Electro Oy

Common Usability Engineering Pitfalls

What could possible go wrong? Expected and unexpected outcomes from the usability engineering process based on real life examples - by Andrea Schütz-Frikart, Human Factor Speciailist, Frikart Engineering GmbH

Post-market surveillance, Transition from MDD to MDR

The lean and mean approach to performing MDR post-market surveillance using a realistic framework - by Stephanie Grassmann, MedTechXperts GmbH

Modular Design Control Documentation

Can Design Control Documentation be modularized and re-used in several Medical Devices? Discover the Pros and Cons - by Karl Larsson, Design Control Documentation Expert, Aligned AG

 


Time and Place

  • Date: Thursday May 17th
  • Time: 08:15 - 13:00
  • Place: HWZ University, Zürich

Presentations are held in German. Slides written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel and other industry professionals engaged in medical device development.

Registration

We are looking forward to see you at this seminar!

Registration Fee: 125 CHF

30% early bird discount for registration before May 1st.

 

 


Location

Address: HWZ Hochschule für Wirtschaft Zürich, Lagerstrasse 5, Zürich

 

HWSMap

 


About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

November 21 2017

Last week we met up with some of the Swiss Aligned Elements users at the Aligned Elements User Conference 2017. It was a very rewarding occasion for me and our team. For ten years, we have grown together with our customers and many of the best improvements we have done to Aligned Elements, are ideas from our customers.

It is not always about new features

It is easy to get locked into the thought process of adding new features as an ISV. However, this user gathering underlined how much unlocked potential lies in slightly tweaking existing features, features that might not look very impressive on the surface but still has an enormous impact on the usability due to its frequent use. For us it was a real eye opener to hear about the large impact of two small features called "Reset Format" and "Paste as Plain Text". The participants had some good suggestions for improvements that we certainly will implement for the next service pack.

Different Users have different needs

As the discussion went on, it became clear that the needs of the groups "Frequent Users", "Infrequent Users" and "Administrators" are quite different. Whereas the Administrator representatives requested better support for User Management and changes made over large Project sets, the Infrequent Users were in greater need of clearer work instructions and an interface adapted to their specific tasks. One user compared Aligned Elements with Photoshop, "if you are a power user, Aligned Elements is extremely powerful, but if you only log in every six months to tick of tasks assigned to you, the interface is intimidating and do not do much to guide this user." We have great ideas in this area that we hope to be able to include in our next version.

Follow that document

Several users pointed out that Document Management, Review, Release and Sign-off actions have potential for improvements, both in scope and implementation details. This is something we are aware about and the user feedback delivered during the conference was very helpful on these points.

We are grateful to the participants for having joined this year's User Conference and will do our best to incorporate the improvements and suggestions in future Aligned Elements releases.

googleplus facebook