We at Taipuva are well aware of the needs of the medtech industry, and at the same time we bring in expertise how to make requirements management benefit the whole product development and management.
What are the challenges in medtech industry?
Medtech is one of the industries where specifying requirements and having a controlled process for reviewing, approving and changing documentation is demanded by law. A general business aspiration is to bring products fast to the market. Furthermore, software and AI (or machine learning) make the products even more complex than before. How to match all these contradictory demands? This is something why companies turn to Taipuva for trusted advice.
The world of standards is not constant, and there are also differences depending on your target market regions. Handling changes and their impacts in an effective and secure way is the point where proper digitalized approach significantly pays off. Mastering product variants or even the required documentation for different regions might be another headache, which can be eased, too. Having one centralized and managed library of all the high-level requirements and being able to control their effects and changes to actual products reduces the needed time for development and documentation.
The ability to manage the entire product development process in an efficient way should not be underestimated. As an example, our customers have stated that in medical software projects in the share of work that goes to documentation alone is greater than 70 %.
The relevance of traceability management is also significant. There are estimates that maintaining traceability and working with that take 20-25 % of project effort, when handled manually.
The numbers speak for themselves. It is a no-brainer to see that an investment to digitalize and automate effectively will give a fast and significant return. You might want to consider the level of automation of traceability. Namely, if it is not 100 % then there still are manual gaps, which take constant effort. Doing it 100 % automatic is the only way to get productivity and compliance to a whole new level.
Get products developed – faster
Product development under strict regulations can take ages, with all the needed processes and documentation. But there really is a better way – and we know how to walk it!
What is requirements management and why is it so important in medtech?
Like mentioned earlier, requirements management and traceability are a must. Period. But the standards do not say, how one does everything. Most importantly – could requirements management be something of a benefit instead being a documentation burden?
If you think more closely, managing product requirements in a structured way is a backbone for the most essential product information – or it can be made as such, therefore serving the needs for product management as well. Doing it right will have a positive effect to the whole lifecycle of your product.
Many faces of requirements management
No matter what you are developing, it all starts with requirements. See our vast experience how you can apply modern requirements engineering to numerous, very different use cases.
What legal requirements and standards must be followed in the medical device industry?
When a medical device or service is to be placed on the market, it must be CE marked, which means that the manufacturer is responsible for ensuring that the product or service complies with the Medical Device Regulation. It must be safe and have specified performance. The label is designed to ensure high safety for patients and healthcare professionals.
In May 2021, the Medical Device Regulation (MDR) was adopted, which regulates all medical devices on the market. It is a regulation, in contrast to the previous directive, which means that it applies as a national law in all EU countries.
In addition to meeting the regulatory requirements, it is a challenge that there is currently a shortage of notified bodies that are accredited for MDR. Another challenge is that the accredited ones do not have capacity to process applications. It is difficult to get a quick processing, but our experience tells us that a clear process and documentation speed up the approvals.
In addition, specifying requirements in a structured way produces a clear structure to which verification and validation (V&V) shall be based on. Product safety and cybersecurity hazards and risks also have a natural (and required) relation to requirements and V&V.
This is where traceability comes in, and you realize how complex it can be to manage the links between all the design entities. Traceability is the first thing that audits will look at, because it is by far the most important factor in ensuring that the documentation is correct.
“Efficiency improvement up to 80 %. Thumbs up for Taipuva!”
– Pauli Innamaa, Head of Concepts and Methods
Digital system supports requirements management of medical devices
To succeed in meeting all the requirements placed on medical devices today, you must have a digital system supporting requirements management – for the whole product lifecycle. By digitizing your quality management system (QMS), you not only get an efficient way of working, but at the same time meet the requirements for medical devices and IVDR (In Vitro Diagnostic Medical Devices).
Taipuva helps you implement structured requirements management and systems engineering methods with powerful tools, all to achieve more efficient projects and faster product development with automated traceability.
What Taipuva has in the pipeline is a scalable digitized solution for QMS processes that is validated according to ISO 13485, and that also has electronic signatures for all documentation (FDA 21 CFR Part 11 compliant).
Would you like to know more about how we can facilitate your work with systematic requirements management?