January 29 2015

"If it is not documented, then it has not been done", according to the FDA saying. "Documentation not available", or "Documentation not adequate" are most frequently cited deviations in FDA Warning Letters. The effects of inconsistent documentation can be devastating, implying postponed market launches, product withdrawals and fines.

The reason for this flood of FDA 483 warning letters, addressing seemingly obvious and simple errors, is not that the medical device manufacturers are ignorant or incompetent.

It is simply hard to keep the DHF documentation consistent. 

The documentation requirements are many and detailed, the development projects often spans over a long time-period, involves a large number of alternating team members, all contributing to the large set of deliverables that make up the Design History File / Technical File. The deliverables are highly interdependent and a small change can cause unexpected ripple-effects over large parts of the documentation.   A considerable amount of the total project effort is thus placed in the handling and management of the DHF.

Not long ago, I was contacted by a customer. He had recently taken over a project with the objective to take the product to market. After a brief introduction, he found the project to be in a miserable state. The project had switched project manager four times during the last four years, the team members were all new, knowledge about the documentation process was lacking.

 In short, the situation was very opaque. 

The project manager wanted help with assessing the current state of the development documentation and within 10 minutes, we could extract the following information from Aligned Elements:  

  • About 20 Requirements lacked traces to Specifications. They were all software related and entered by the same person during a short time-span about two years ago.
  • All Specifications had adequate Test Cases assigned.
  • About 10 Test Cases had never been executed. None of these were functional Test Cases and they had all been entered after the last milestone.
  • About 10 Test Cases had the current state "Failed". Most of them had to do with reliability, maintenance, spare-parts and life-time tests.
  • About 15 Risks were insufficiently mitigated.
  • About 10 Mitigations were not verified or implemented.
  • All Word documents were up to date.

The project manager finally felt that he had some grip of the situation. He now had concrete errors to fix and also the names of the people to contact to get detailed information about each individual inconsistency. 

Design History File - DHF

Aligned Elements addresses the issue of incompleteness with a range of integrated and automatic consistency and control functions. Aligned Elements is able to:

  • In real-time, highlight any gaps and inconsistencies on any content set in the project.
  • Provide reports that present a clear overview of the current consistency state of the project.
  • Guide the user through a predefined process path to make sure errors are not created in the first place.


By the application of configurable validation rules, real-time checks can be executed on the documentation continuously. Faults and gaps are uncovered well in time before the auditor arrives or before the documentation is submitted to the notified body. 

Knowing the state of the development documentation is invaluable for a medical device manufacturer. The list of open errors, representing the project’s “Documentation Quality Debt”, is an excellent estimator for how much work remains until the documentation is ready for release.

Reducing project risk by making the current documentation state transparent is an excellent way to increase the chances of a successful product launch. 

Learn how Aligned Elements can help to organize your Design History File

Schedule a live demo and let us show you how Aligned Elements keeps your DHF complete and consistent

January 19 2015

Our friend Dr. Samuel Fricker, assistant professor at Blekinge Institute of Technology, is co-authoring the publication "Requirements Engineering for Digital Health".


According to the information, this book:

  • Includes practical step-by-step guidelines, examples, and lessons-learned
  • Addresses domains of central importance for the aging society
  • Bridges cutting-edge research and relevant business and engineering practic

Samuel provided valuable help when we compiled our report on "Requirements Engineering for Medical Devices".

December 12 2014

It is not hard to guess that Mobile Medical Applications (MMA:s) are going to be a hot topic for 2015. Just in time for Christmas, the market is flooded with wearables and connected devices for health related applications. It is also predicted that we will see a rapid growth in this area, bringing in a whole new group of companies (mobile app makers) into the medical device world.


From a documentation point of view, there might be some confusion on what really counts as a MMA. FDA has put together a great set of information, explaining their take on the subject with some reasonable helpful tips on how they will make their judgement. I recommend that you take a look. 

Learn more about how Aligned Elements can help you to manage your medical device documentation.

Or contact us for a live demo.

October 20 2014

I was recently asked by a Business Developer at the Sahlgrenska Science Park Start-up incubator in Gothenburg, Sweden, about any useful medical device development documentation tips.

The concrete question was: "What is the absolute minimum a med-tech start-up must know about development documentation during the early phases in order to not suffer from mistakes later on?"

The development documentation essentially describes how you have developed the medical device.

This includes, but is not restricted to:

  • How you planned the development work
  • The requirements of the device
  • The specifications of the device
  • The Verification and Validation of the device
  • How you made sure that the device does not pose risk to patient safety

At product launch, all these things needs to be in place, with all documents properly written, reviewed, signed off and archived.

It is obvious to everyone involved that documentation means work.  A lot of work.  (We assess that up to 30% of the total development effort is spent on documentation). It is equally obvious that conducting this documentation work ties down resources that (due to mutual exclusion) is not spent on something else.

The practical effect of this is that once you start with the formal development (and documentation) process, everything else seems to slow down. And hence, there is often a question about "When does the formal development actually start?"

Now, while the regulations does not do any distinction between "formal" and "informal" development (there is only "formal" development), these start-ups are in such an early phase that they do not even know if there is going to be a product at all, or what the product should be.

What do companies in this situation have to know about development documentation?

Here is my advice:

  1. Once you start with formal documentation, you shall follow "Good Documentation Practices" (called "GDP"). Google it! It is essentially a set of rules describing how to practically write documents. GDP originates from the pharmaceutical industry but it is also widely applied in the med tech field. GDP is utterly concrete in its advice and includes statements similar to:
  • "If it is not documented, it does not exist"
  • Use page numbering "x of y pages" in all documents
  • Sign documents with Full name, signature and date in indelible ink (no pencils)
  • Use "YYYY-MM-DD" as date format
  • Make documents uniquely identifiable and so on.

Many of these rules are common sense and the sooner you start to use them, the better. Therefore, there is nothing preventing you from starting to use GDP right away and the extra work incurred is relatively low.

  1. Taking a medical device from prototype to market-launch is notoriously burdensome, especially due to the regulatory aspects. This phase, which by some is regarded as the “formal development phase”, requires a good deal of preparatory groundwork. It is very important to understand this. Before you start with “formal development”, your development framework needs to be in place.

A good place to start is to get familiar with some of the most basic medical device development concepts, and to have a good grip on these before the “formal development” starts. Even though these concepts have a limited influence on how you write documents during the early phases, knowing them well before formal development starts will make the transition from prototype to product a whole lot smoother.

I have listed some of the most important concepts below.

Quality Management System (QMS)

The QMS is a set of business processes that are meant to "assure product safety and efficacy".  Essentially, it formally describes how your company performs these business processes (such as purchasing, manufacturing, development, service, HR etc.)  in order to make sure that the patient safety is not at risk.

 This is what you need to know:

  1. You have to have a QMS if you want to develop and/or manufacture medical devices.
  2. It takes some time to set up a QMS, so get working on this in due time before the “formal development” starts.
  3. The processes described are not restricted to development, it encompasses aspects such as purchasing, service, support, HR, manufacturing etc.
  4. You don't have to write the QMS yourself. Several Regulatory Consultancies provide Out-of-the-box QMS-kits that can be adapted to your specific needs.
  5. The standards covering this aspect are called “ISO 13485” in the EU and "21 QSR 820" in the USA. When people say that they have "received their ISO 13485 certificate", it means that they have set up the QMS according to ISO 13485 and somebody has checked it.
  6. If you do not have regulatory expertise in your company, I strongly advice that you get outside support to set this up.

Target Markets

Each geographical market has its own set of regulations. Even though the global community is working on harmonizing standards and norms, there are still local particularities.

Broadly speaking, regulations in USA and China are considered more "difficult" to comply with whereas EU and Canada is considered less "difficult".

Selecting target markets does therefore have a large impact on the development documentation required later on.

Intended Use

The "Intended Use" stipulates the use your product is intended for. This probably sounds straight-forward. However, I cannot emphasize enough the enormous impact the intended use has on the documentation burden lying ahead. Note that the intended use is not “what the device is designed for” or “what you can do with the device”. It is what you say your device is to be used for,

The classic example is the scalpel.  If you stipulate the intended use to be “cutting tissue” in the general sense, then it is a Class I device according to the FDA. But if you label the exact same scalpel to be used for ophthalmology or eye surgery, then it is suddenly a Class III device.

Furthermore, according to the FDA, if your device is equivalent to a device already existing on the (US) market, then less work is needed to bring it to the market. The “equivalence” is largely decided based on the intended use.

Therefore, the way you word the intended use has a large impact on the regulatory pathway and thus the accumulated effort of bringing your device to the market. It is important that you consciously and carefully formalize the intended use and that you also develop the device according to the intended use.

Product Classification

The "Intended Use" plus "target market" will render into a product classification for each target market.  FDA and EU regulations use different classification schemes. Generally speaking, the classification describes which and how much data you need to provide in order to get regulatory clearance. This can vary a lot between classifications.

Generally the following applies: the higher risk the product poses to the user (patient, nurse or other), the higher the classification. The higher the classification, the more work (including documentation) is required to prove that the product is safe.

If your device is in an area where you need to prove its effectiveness and reliability on living beings, you need to go through proper Clinical trials (see http://en.wikipedia.org/wiki/Clinical_trial ). Clinical trials are notoriously expensive. Therefore, it is crucial that you have a formal process in place, otherwise the data will not be valid and you have to start all over.

Risk Management

Since patient safety is such a central concept in medical device development, the sooner you get familiar with Risk Management the better. There is simply no way around it. In order to launch you product, you have to have documented proof of that you device is safe to patients and users. The normative standard to look for is ISO 14971 which describes how risks are identified and controlled. There are plenty of seminars and webinars available on risk management introduction and it is well spent time to visit one or more early on.


Medical device development documentation constitutes a large part of total development effort. By learning how to apply Good Documentation Practices during the early phases to all your documents, you will feel more at ease with the necessary work methods when the “formal development” starts.

Switching from “non-formal” to “formal” development is not done in an instance. Setting up the development framework will take some time and you should plan accordingly. I have tried to introduce some of the most important medical device concepts in this text.

If you plan to stay in the Medical Device development field for some foreseeable time, regardless of role or occupation, these are concept that you have to get familiar with. They will permeate your work. Even though they might not seem relevant to start-up teams, it is necessary to know these things in order to make the notoriously difficult transition from prototype to market-ready as smooth as possible.

If you have questions or want to know more about these things, please This email address is being protected from spambots. You need JavaScript enabled to view it. and we will do our best to help you.

Learn more about how Aligned Elements can help with achieving regulatory compliance

Request a live demo and let us show you how Aligned Elements can manage your documentation

October 04 2014

Preliminary Hazard Analysis is a risk assessment technique performed in the early the design phases. It is a powerful method to document and assess device risks without having the full implementation completed and to highlight problematic risk areas early on.


We have previously discussed how the PHA compares with the FMEA method in Aligned Elements and how they complement each other. The templates needed are available here.

Learn more about Aligned Elements and Riskmanagement

Request a live demo and let us show you how Aligned Elements helps you with your Preliminary Hazard Analysis

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