Aligned AG - Documentation

Med Tech Industry Study: "Quality and documentation requirements" ranks as top challenge

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 Medtech 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 a competitive and innovative R&D program when more and more of the development effort is devoted to satisfying regulatory and documentation requirements?

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, the 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.





Meet us at Med Conf 2016 in München 25-28 October

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 are 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!

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Sharpen your Medical Device Development Skills!

Register to the seminar "Sharpen your Skills! - Medical Device Development 2016 in a dynamic regulatory context"

Take this opportunity and find out how to rapidly deliver innovative medical devices as the regulatory landscape is changing.

Key learning objectives:

  • New EU MD Regulation & ISO 13485:2016 - Assess and adapt, change and comply
  • Design Control Best Practices - common mistakes and lessons learned from real project cases
  • Death by documentation - innovate or administrate? Uncover documentation inefficiencies in your DHF process
  • Risk Management when the heart stops - An ISO 14971 Case Study from a Class IIb product

Register now to reserve your seat!

Our event is aimed at medical device development professionals, project managers, QARA professionals, software managers and architects, designers and developers, and other personnel engaged in medical device development. We are at this seminar dealing with the fundamental question of medical device development: how to rapidly develop and deliver innovative medical devices while ensuring compliance.

sharpen your skills!

Take the opportunity to sharpen your medical device development skills and update your knowledge at our half-day seminar on the existing and upcoming challenges in today's dynamic regulatory environment.

Register now to reserve your seat!

When: Wednesday, May 25th, 08:30 - 13:00

Where: Hotel Marriott Courtyard Oerlikon, Zurich (directions)

Price: 125 CHF  (Note! 30% early bird discount for registrations before May 1st)

Presented by: 

  • Mario Gennari, Regulatory Affairs and Design Control Expert, Prismond Group AG, former Lead Auditor at TÜV SÜD
  • Christian Steiner, Quality Assurance Manager, Thoratec Switzerland GmbH
  • Anders Emmerich, CEO, Aligned AG

Hosted by: Prismond Group AG / Aligned AG

For any questions, please feel free to This email address is being protected from spambots. You need JavaScript enabled to view it.

Start your road to efficient medical device documentation here!

You spend too much time and money on documentation.



So what is your plan?

The regulations of the medical device industry require us to produce a pretty hefty chunk of documentation to show that the device is safe and efficient. If the documentation is not compliant, then it does not matter how safe, secure and performant the device itself it. Therefore, the documentation aspect that receives the largest share of attention is compliance. The most common path to a compliant stack of documents is to throw heaps of man-hours at the problem. Quantity seems to be the weapon of choice in many firms.

As a consequence, a large number of people get involved in the documentation creation and maintenance, especially people residing in the R&D part of the organization as most companies do not have Document Officers or documentation experts in their organization.

However, engineers and scientists are not necessarily the best writers (And they probably have no ambition to be.) Staff who are necessary for other tasks struggle to find the time to write these documents, and so the documents they do produce may be of lower quality than their usual work.

The effect on these people is often a suffocating feeling of inefficiency and frustration of spending an un-proportionally large part of the working day on menial documentation tasks, deciphering SOP:S and unpractical standards to compile documents that no-one reads (apart from the auditor).


Our studies show that up to 30% of the total project effort is spent on documentation required by regulations. There is also an overwhelming consensus in the industry that this is far too much. Money and time are inefficiently spent and morale buckles as the workload increases.

The good news is that these problems can be fixed. The bad news is that you are going to lose time, money, and people until you fix them.

Excelling at documentation efficiency is not intuitive to many R&D-centric organizations. However, considering the situation described above, good documentation practices is an investment. In the medical device industry, it is even a competitive dimension.

Your company can be efficient!!

Some good starting points are:

  • Make documentation efficiency a prioritized objective using measurable goals
  • Assign a responsible Manager
  • Set up a tight collaboration between the people writing templates and SOPs (Quality people) and the people using the templates and SOPs (R&D people)
  • Analyze your documentation processes
  • Apply the right software tools to automate documentation tasks

You can start right away!

Download our Medical Device Documentation Self-assessment paper and take a few minutes to complete it. We assure you that you will have started the road to more efficient documentation within the next 15 minutes!