FDA & MDR pressure on Design and Development Process

Medical devices, in-vitro diagnostics and software for healthcare – all need to fulfill the new EU Medical Device and In Vitro Diagnostic Regulations (we use MDR for short). The regulation demands a Quality Management System (QMS). This is basically required of all actors in the delivery chain.

For the actual product development process there are a number of requirements, in addition to the QMS practises (see the figure below).

 

 

 

The usual approach is to apply the QMS practises and other “extra” on top of the normal development and maintenance. It may look like the figure below illustrates: your experts need to write many documents and then handle traceability manually with spreadsheets. The threat is that if you don’t do all this, the process and the product do not comply and you can even be out of business.

 
 

Your current IT system landscape might look something like in the following diagram. A document management system provides the basic quality aspects for document handling, but it does not support product development experts in their work. It also does not facilitate managing traceability of individual things, because those are small pieces of information inside files: sections in documents or rows in Excel files.

 
 

What Polarion Offers?

It’s quite clear that in the modern digital era there must be a better way. How can a single solution be a game changer, as you still need to do what you need to? The key is to realize that this work is not “extra” if the needed quality is built-in the process. This way quality also drives patient safety into the design, as intended by the regulations and standards!

You need a digital platform that makes such a way of working possible.

Your wish list:

  • Manage all processes and information with one tool
  • Connect different processes and link individual things together for traceability
  • Carry out normal development with the same tool, and not create separate silos
  • Document lightly as you go
  • Follow defined workflows so that you get the process right
  • See the impacts of any change easily

You have it all in Polarion!

 

 

This is why it has become so popular among Health Tech companies.

This means you can get your product to the market months earlier. What’s more, Polarion enables things that you probably could not even wish for:

  • No change to current ways of working because of Polarion’s ingenious LiveDocsTM that allow normal-looking documents, but you have control over the individual items in them
  • Electronic signatures for quick review and approval of changes
  • Combine agile and regulatory compliance
  • Import MS Office files and integrate to existing systems

Nobody wants yet another tool, but as the advantages are clear and the alternative is to keep on wasting expert resources year after year, the benefits outweigh the investment.

 

Who Benefits From Polarion?

The scope of Polarion is focused around the design and development process. It is a subset of the big QMS picture, but it comes more and more significant, when your product is:

  • Software or it involves software, OR
  • Otherwise complex or big, OR
  • Highly safety-critical

You could easily think that such a tool is only suitable for big organisations. However, it is very scalable and the smallest installations only have a handful of users. At the large end there are thousands of users around the globe.
 

What does Taipuva Offer as Siemens Solution Partner and Reseller?

Our role – if you allow – is to be your partner and make sure you get the full benefits of Polarion. We know product and software development and how to make them compliant, efficient and agile.

We have been in business since 2011, operating mainly in the Nordics. We have compressed our expertise into a health tech process for Polarion that you can take into use in days, not weeks or months.
 

Would this be useful for you? Book a free 30-minute consultation session to get answers!

Benefits for Your Business

Polarion provides remarkable business benefits:

  • Reduce the risk of non-compliance and severe errors
  • Launch your products earlier
  • Save effort and money in development and maintenance
  • Gain predictability to development work with real-time reports
  • Get repeatability with unified process and information reuse

    • You can rely on Siemens’s Polarion for a solid and long-term platform to build Your way of excelling in the industry with Medical Device Regulation.

 

Book a free 30-minute consultation session!

 

Some of Our Customers

 

Planmeca says: “Polarion helps to speed up our processes and satisfy the regulatory requirements by providing end to end traceability between requirements, design and verification.”

Innokas Medical says they have seen significant efficiency gains. Pauli Innamaa, Head of Concepts and Methods, tells Polarion saves huge amounts of time in the development work and documentation. Savings have been up to 80 %, especially in managing traceability and reusing information.