On March 3rd, the 2016 revision of ISO 13485 was finally released. The new revision is essentially an evolution of the 2003 revision and includes a number of changes and clarifications.

For Aligned Elements users, a change in section 4.1.6 might have some important implications. Whereas ISO 13485:2003 did not explicitly require computer systems used in the quality management system to be validated, the 2016 edition certainly does. ISO 13485 is now finally on par with FDA 21 CFR 820 on this matter.

Computer Software Validation is used to ensure that each computer system fulfills its intended purpose. It prevents problems with the software to reach the production environment. CSV is today used in many regulated industries and is today regarded as a good manufacturing practice.
Aligned Elements certainly fall into the category of Computer systems that must be validated according to ISO 13485:2016 and FDA 21 CFR 820. If you do not have CSV process in place, we do have some things that may help you.

Why is Aligned Elements not validated by Aligned AG?

Aligned Elements falls into the GAMP 5 Software category 4 - "Configurable Software". AE is a highly configurable software with the purpose of mapping the customer's QMS, as opposed to forcing the customer to change his processes and templates to match Aligned Elements.
When validating a software of Category 4, it is of course the particular configuration of the software that is validated. Since each Aligned Elements customer is using a different configuration (each customer has its individual QMS), we cannot foresee which configuration our customers will use.
As mentioned, we do supply a number of useful tools to make the validation process faster.

What do I need in order to validate Aligned Elements?

Even though ISO 13485:2016 and FDA 21 CFR 820 require Computer Systems used in the Quality Management System to be validated, they do not explicitly described how to do it. This is up to each organisation to decide.
With no intention to be a complete listing, you need at least the following things:

1. A Standard Operating Procedure (SOP) that describes how Computer Software is validated in your organisation
2. A validation plan, that describes:
   • INTENDED USE of the computer system in question
   • WHAT are you validating, i.e. which name, version, and configuration of the software including manuals and supplier information and target environment
   • WHY are you validating this software to this particular extent (hint: the GMP Software Categories are a good starting place. A risk-based approach is also a viable starting point.)
   • WHO is responsible for the software, for the maintenance of the software and who is responsible for the validation
   • HOW do you intend to validate the software, what the acceptance criteria are, and in particular how do you intend to handle software errors detected during the validation
   • DELIVERABLES i.e. the documentation you intend to provide
3. Requirements and/or use cases describing how you intend to use the Computer Software.
4. Tests verifying that the use cases and documenting any deviations found.
5. A Validation Summary or Report stating the result of the validation, preferably with some kind of traceability, and whether the Computer Software should be cleared for use in the production environment

To make this process a bit simpler, we provide our customers with a pre-filled example validation kit of Aligned Elements that can be adapted to the individual needs of each organization.

Can Aligned Elements be used to document the validation of other systems?

Absolutely. Aligned Elements is very well equipped for documenting the validation of other systems (provided AE has been validated, of course). AE supports all steps of the CSV process, from evaluating the validation extent via checklists or using a risk-based approach, documenting requirements, use cases and test cases, executing test cases, analysing the test results, and finally supplying the necessary traceability reports.

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

Within the last 24 months, mobile health technologies (eHealth apps) have radically changed the way we think about health and medical devices. The combination of smart apps and wearable sensors has brought monitoring and diagnostic power into the hands of the patient, increasing value and utility, often to a very competitive price. There is a surge for patient-centric offerings across the industry, truly leveraged by the new mobile health technologies. 

Ava Women is one of the companies that has moved quickly in the right direction and with the product “Ava”,an advanced fertility tracking bracelet, they assist women and couples in narrowing down the right timing of a successful conception.

We were lucky to get a word with Mr. Philip Tholen, Co-founder and VP of Operations of Ava Women, and took the chance to ask some questions about the opportunities and challenges that face a "wearables"-company.

Mr. Tholen, we have seen a host of consumer electronics companies, including Apple, Microsoft, and Google, with little or no experience in medical device development, trying to penetrate the market with wearable technologies, banking on their expertise in consumer products. 

There are also more traditional companies such as Medtronic, with substantial experience in medical device development that are now jumping the bandwagon, attempting to entering this new playing field.

Looking at the two extreme ends of this spectrum, where would you say the Ava story fits in?

I would say we are positioned right between these two extremes. On one hand, we have a Class I regulated medical device with all its pros and cons. This demands for compliance with GMP, FDA Class I, taking IEC 62304 into consideration, etc. On the other hand, we focus on selling directly to the end-user. In that sense, we have to market our medical device as if it was a consumer product. Striking this balance is not always easy.

With numerous players grabbing for their share, I assume that speed is of the essence in the mobile health market and time-to-market is critical. What measures has Ava taken to make sure that the development proceeds as fast as possible?

Exactly. Our market operates as fast-paced and as short-cycled as a classical consumer market. But in the background, we still have to assure compliance and organize our company in the classical medical device way. Guess how long the lights are on in the Ava-atelier each night!

In order to be fast, we massively parallelized all process steps right from the start. For example, we started hardware development even before we had the clinical study results which delivered the data we need and which confirmed that the sensor concept we chose works. We made so many educated guesses! But luckily, it always worked out and we never had to go back to the drawing board due to inaccurate assumptions.

Furthermore, we purposely selected “off-the-shelf” hardware technologies and components. We neither had our suppliers develop or modify components specifically for our purpose nor did we trust in suppliers’ statements such as “we will have this new product ready when you are going into production”. Only what’s already been commercially available in the mass market made it to our product concept shortlist. We could effectively eliminate the risk of supply-related delays using this approach.

Developing a working medical device is a formidable task per se. Doing it in the strictly regulated environment of medical devices is usually not making it easier. How has Ava, as a start-up company, managed to tackle the regulatory challenges of the medical device market?

Since the beginning we kept an eye on regulatory aspects of product development: for example, we have always made sure that candidates have experience in this field when we selected key team members. Furthermore, during the hardware supplier selection process we only considered ISO 13485 certified companies. On top of that, we have hired a highly experienced professional who is busy refining our QMS and accelerate us through an ISO 13485 certification in due time before market launch. All of these steps might be expensive and seem much work for a startup, but they are part of our strategy to become a cutting-edge digital health company providing state-of-the-art technologies for the end-user as well as for medical professionals.

There has been much debate lately about cybersecurity and data integrity when it comes to mobile health applications. Even FDA has concerns about how patient data is stored, transferred, and accessed. How has Ava addressed these questions?

We are taking the FDA guidance on cybersecurity very seriously. Confidentiality and data integrity is paramount for us, as is the trust our customers have in our product. All data in our application is stored, handle, and transmitted with utmost vigilance. Our security concept is being challenged and improved periodically, and it will also be audited by independent third parties. However, making sure that security measures do not impair the usability of our device shall not be neglected. Luckily, I am confident to say that we have the right team in place to cope with these challenges.

Finally, based on your experience with Ava, do you have any advice to other start-ups currently thinking about embarking on a similar journey?

Do not underestimate the commercialization process of a medical device! Having a working prototype is a good start, but there are many other pieces that have to be put in place before you can place the product on the market. Having the right team and the right partners will certainly make that part of the journey less rough.

AVA Women uses Aligned Elements to manage their medical device development documentation. 

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

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

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.

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

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