Aligned Elements is a Medical Device application lifecycle management (ALM) solution enabling fast development and regulatory compliance through improved Design History File management.

October 29 2016

A few years ago we could read articles claiming "Exoskeletons will one day replace wheelchairs". That the FDA regulates these kind of devices is a clear sign that they are about to enter the mass market.

Miniaturization of electronics, a steep drop in manufacturing costs of mechatronic parts, increased computational power, more powerful batteries. A number of recent technical developments converge into the realization of exoskeletons growing nearer and nearer.

In this rapidly expanding field, competitors are scrambling to put their new models onto the market.

exoskeleton

In the beginning of 2015 FDA announced that power exoskeletons will be classified as Class II devices with Special Controls, which clarified the regulatory situation for these kinds of wearable devices. The special controls have been put in place to address a number of risk factors identified by FDA to be associated with the usage of powered exoskeletons.

For those used to medical device development, both the risks as well as the suggested requirements are straight forward. They include among other things, thermal and electric safety, biocompatibility and the obvious risk of falling to the ground.

To help exoskeleton manufacturers getting up and running with their documentation, we provided the Aligned Elements Exoskeleton Extension Package containing:

  • 9 Potential Hazards (including mitigation strategies) outlined as exoskeleton associated risk factors by the FDA
  • 38 exoskeleton Special Control Requirements deduced from 21 CFR Part 890 Docket No. FDA-2014-N-1903

This will give manufacturers a predefined starting point of setting up their Design History File with the intention of accelerating the documentation effort.

The Aligned Elements Exoskeleton Extension Package is downloadable here: Aligned Elements Exoskeleton Extension Package

 

September 29 2016

We are participating in the Med Conf 2016 25-28 October with our lecture "Death by Documentation - how to identify documentation inefficiencies in your medical device development process"

If you ar interested in how to assess the documentation process in order to find process inefficiencies in your own company, then this one is for you!

The lecture is held by our CEO Anders Emmerich on 27. October at 14:10.

Find the complete agenda here.

If you want to meet us during the conference, please This email address is being protected from spambots. You need JavaScript enabled to view it. and we'll set up an appointment!

B MEDCONF 16 500x500

September 27 2016

The Swiss Medtech Industry Sector study surveyed more than 340 medical device companies in this year’s SMTI industry study, uncovering the current opinions and views in the Swiss Med tech market.

The study claims that "the ever increasing quality and documentation requirements" and the difficulty to "preserve innovative capacity" are the primary challenges to remain competitive in the current market.

For those of us working in the industry for some time, this does not come as a surprise.

Knowing the dynamics operating in medical device development, it is obvious how these two challenges inter-relate. How is it possible to sustain competitive and innovative R&D program when more and more of the development effort is devoted to satisfying regulatory and documentation requirements?

Download the study here: Swiss Med Tech Study 2016

Our own studies show that up to 30% of the total medical device development effort is spent on documentation tasks. As in many other industries, digitalization of processes offers some prospects of streamlining the medical device documentation burden.

Our users say that significant efficiency improvements can be done by applying the right tools. Download your free copy today or ask us for a free online presentation.

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September 16 2016

The 2016 "Documentation Trends and Insights in Medical Device Documentation" survey is live!

Are you alone in experiencing challenges when it comes to Medical Device Documentation? Or is what you feel shared by the industry?

Man with papers

We invite you as a Medical Device professional to share your thoughts on the state of documentation practices by participating in this survey.

The survey will assess how Medical Device organisations manage regulatory driven documentation challenges during the R&D phase.

Take the 2016 Medical Device Documentation Survey now!

August 24 2016

The imminent update of the EU MDR and IVDR regulations has serious effects on Notify Body access. The result might be an increase in company value of manufacturers for second-rate products.

Read the full article here.

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