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

February 27 2020

A smoother and faster IEC/ 60606-1 experience with Aligned Elements IEC/ISO 60601-1 Risk Assessment Checklist

The IEC/ISO 60601-1 "Medical electrical equipment" is the cornerstone document addressing many of the risks associated with electrical medical equipment.

The standard covers safety and performance requirements of medical electrical equipment and public health authorities in many countries recognize it as a pre-requisite for the market access. The standard is notorious for its depth and complexity and many manufacturers experience the task of ensuring compliance as challenging.

The safety testing, certification and global market access approvals done for IEC 60601-1 shall be conducted by an accredited Testing Lab. The manufacturer's collaboration with the Testing Lab is essential for a smooth and swift approval.

As of the 3rd edition of IEC 60601-1, a large number of risk management references were introduced in the standard. The Test Laboratory will request the manufacturer to demonstrate how the product's risk assessment covers the risks items stipulated in IEC 60601-1.

Poor preparation of this step can result in can delay the certification process, requiring an inordinate amount of time during the initial testing phase to correct the risk management files.

IEC60601

To facilitate this step, Aligned has developed an integrated assessment method in Aligned Elements, that assists the manufacturer in demonstrating compliance with these risks.

By assessing and connecting the IEC 60601-1 risk requirements with the product risk assessment already existing in Aligned Elements, a compliance assessment document can be automatically generated and presented to the Testing Lab.

Aligned Elements IEC/ISO 60601-1 Risk Assessment Checklist - How is it done

  • The checklist contains approx. 80 risk checklist items from IEC 60601-1 which are imported into Aligned Elements.
  • Each IEC 60601-1 risk checklist item contains the clause reference, the demonstration requirement, explanations and examples of what the risk intends to cover, all to facilitate the identification of the corresponding risk in the manufacturers risk assessment, already located in Aligned Elements.
  • The manufacturer addresses each risk requirement, deeming it either as "not applicable" for his product (including providing a qualification for the answer), or applicable and then tracing the risk requirement to the corresponding existing risks in his own risk assessment.
  • When completed, a Compliance Assessment Word Report is generated and can be presented to the Test Laboratory.
  • With this compliance report, the Test Laboratory representative can quickly assess your IEC 60601-1 risk related complicance level

The benefit of the Aligned Elements IEC/ISO 60601-1 Risk Assessment Checklist is a massive reduction of time spent at the Testing Lab by leveraging your existing documentation!

IEC 60601 1 Checklist

How we developed the Aligned Elements IEC/ISO 60601-1 Risk Assessment Checklist

The Aligned Element IEC 60601-1 Risk Assessment Checklist has been developed in collaboration with former Eurofins Electrosuisse Test Laboratory Manager Karim Bader, currently serving in the swiss national working group CES/TK 62 for "Elektrische Apparate in medizinischer Anwendung" contributing to the development of the international standard IEC 60601-1.

Experts from Aligned will assist you in integrating the checklist into your current configuration and demonstrate its use.

If there is a need to further explain the IEC 60601-1 risk management requirements and identify findings that can be fixed, Mr. Karim Bader, an expert in this field is available to deliver the knowledge and confidence to ensure that your product will be certified without delay.

Contact This email address is being protected from spambots. You need JavaScript enabled to view it. to receive a quote for the IEC 60601-1 Risk Assessment Checklist.

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

 

December 12 2019

Sometimes I get the question "So how much time and money will I save by using Aligned Elements?"

A fair question and a question I can answer with a clean conscience: on average, you will save 30% or more of the time you currently spend on design documentation.

However, some medical device manufacturers can save (and have saved) a lot more than that!

If a modular documentation approach is applied, where reuse of already existing Design Control data is leveraged, there are examples of savings on up to 80%.

In this video below, you can find out more about the possibilities, prerequisites and benefits from Modular Design Documentation with Aligned Elements.

Happy Holidays!

Modular Design Doc Video

 

October 31 2019

Computer Software Validation is something we discuss a lot where I work. Since Aligned Elements is a Medical Device Quality Management System relevant software, our customers make sure that their Aligned Elements installations and configurations are validated.

It is a necessary activity, although not always perceived as bringing an awful lot of value. Sometimes the cost of CSV activities actually supersedes the cost of acquiring the software itself. 

I sometimes get the question if I know any best practices when it comes to Computer Software Validation and I have made a few observations from my CSV experiences. 

Let me tell you about the top 3 things that has an impact on the Computer Software Validation effort:

1) How many test cases do you perform?

It is dead simple. More test cases (note: not necessarily "more requirements") is more work. But do YOU have to perform all those test cases? What if the supplier has already verified them? 

You are very much allowed to leverage existing supplier documentation and testing records. A properly conducted Supplier / Vendor assessment can lead you to the conclusion that the suppliers verification documentation suffice. Remember that the risk we are trying to mitigate with a Computer Software Validation effort is primarily about patient safety. A software like Aligned Elements is not directly involved in the patient safety and this fact can be leveraged when assessing and deciding on the validation scope. 

2) How do you record the test results?

The bulk of the CSV work resides in performing and recording the test results. The way you record those results can have a significant impact on the overall effort. In order to record that the actual behavior of a test step corresponds to the expected behavior, is it enough to tick a box (passed/failed)? Or do you need to write a text? Or do you need to make screenshots? As you can imagine, there is a huge difference between the former and the latter.

"But are we not required to take screen shots?".  The short answer is "No, you don't". Not if you do not think it proves anything more than the tester checking a box. FDA requires you to select your own methods and tools for quality assurance. If you have a good case for not making screen shots (which I think you have), you do not have to.

3) Who (and how many) has to sign all these CSV documents?

This might sound a bit odd but more than once I have run into cases where the validation is completed and everything that is missing is a signature from some top management figure. And now we run into a buy-in problem. If this guy has not been involved CSV approach and suddenly disagrees with how it was conducted ("BUT THERE ARE NO SCREENSHOTS?!?"), it can have a significant impact (significant as in "redo the validation").

So the lesson here is to get early buy-in from the people that sign the document. On a general level, reducing the number of signatures will speed up any documentation process. And you might want to contemplate on the necessity of having the IQ, OQ and PQ plans / reports in different documents (more documents to sign) or if you can combine them.

Validating Aligned Elements

When you acquire Aligned Elements, you get free access to our internal verification documents to use in your vendor assessments as well as pre-filled Validation documents to kick-start your validation. Contact us for more information on This email address is being protected from spambots. You need JavaScript enabled to view it.

What's up ahead regarding Computer Software Validation?

FDA announced that their much anticipated "Computer Software Assurance for Manufacturing, Operations, and Quality System Software" draft guidance should be out in 2019 but now it seems like it has been postponed to 2020. The new guidance is supposed to use a more agile approach, including a risk-based and value creating perspective on CSV activities.

 

googleplus facebook