Save time & effort – Secure compliance
Is your traceability matrix on a spreadsheet? Are you documenting regulatory compliance after the product is ready?
We help organizations bring better ways of working to life – not just on “paper” or with Word/Excel templates, but fully digitalized. The best part is that you don’t need to change that much!
UNEEG MEDICAL A/S
“Taipuva has helped us with ideas how to set up processes. They wish to understand our needs and propose solutions that work.”
– Flemming Jørgensen, System Architect
Design and development with risk control
Medical device design controls include specifying design input (requirements), conformance of design output to them and intended use (verification and validation), processes such as design review and maintaining design history file (DHF).
Risk control is a separate process, but as EU’s Medical Devices Regulation (MDR) dictates, pretty much everything starts with risk assessment, it is very clear that risk management shall be an integrated part of the whole design and development.
Key requirements for design and development process
We can summarize the key regulatory requirements affecting D&D as follows:
- Need to document how you design your product (intended use, needs, requirements, design, architecture)
- Such requirements need to include relevant standards (safety, cybersecurity, usability)
- Need to plan and specify how you verify that the product realization corresponds to the requirements – and really show traceability to actual, individual defined requirements
- Need to plan and specify how you validate that the product “works” the right way as intended and user needs are met – and again show traceability
- Need to record results and evidence of verification and validation
- Need to identify, understand, control and prevent possible hazards that may take place with your product – and document carefully your risk management process so that is also shows traceability to different design artefacts, as well as justifies your risk mitigation actions and shows evidence of their effectiveness
- Need to carry out design reviews and officially approve certain documents and/or artefacts prior to advancing to a dependent design phases
- Work under your general quality management system (QMS) and its standard operating procedures (SOPs)
- Document how you work and gather evidence that you actually worked that way
In brief, there are a lot of things that need to be documented and processes to be followed. Otherwise the product does not get to the market. Period.
Problem of scattering information and lack of traceability
Often working processes are a result of an evolution. We have seen many examples like this:
It may take several forms, but there are some general findings that cause problems and inefficiency:
- Information is stored in multiple different places – even finding it may take time
- Traceability is manual – so it does not help you, but maintaining it takes constant effort
- It’s hard to come up with unified and clear ways of working
- Quality is a separate “layer” on top of everything, and it just makes things “stiff”
- Document review and approval needs “freezing” of certain things, and it can cause long waiting times
- Changing anything is error-prone and causes a big overhead of manual updates and bureaucracy
Ready-made design controls and expertise
It’s quite clear that in the modern digital era there must be a better way that resolves the problems listed above – driving efficiency and secure compliance. Over the years, working with a number of medical device and software manufacturers we have perfected our approach.
Taipuva’s solution combines several critical ingredients of success:
- Service engagement that fits you – we can work together to drive your improvement, or you can just take our solution(or parts of it)
- Capability of unifying all the needed processes and information
- 90 % ready-made solution – proven industry best practises “out-of-the-box”
- The rest 10 % is quickly configurable to make a perfect fit to your exact ways of working
- Simple base processes for easy adoption
We have a track record of getting our customer productive in one week with their improved processes.
Software architecture and detailed design falls into the “box” of Design Specification, so that the requirements of IEC 62304 can be fulfilled. There are also several other process areas that can be supported:
- Digital quality management software (eQMS)
- Product management – Features, versions, variants (product line engineering)
- Software release management
- Agile development and SAFe (enterprise agile)
Feel free to ask us, if you have some questions what’s possible and how it all works!
“Efficiency improvement up to 80 %. Thumbs up for Taipuva!”
– Pauli Innamaa, Head of Concepts and Methods
Advice on medical R&D best practises
With Taipuva as your process improvement partner you will get real results in just few weeks! We combine all you need:
- Knowledge how the requirements of ISO 13485, ISO 14971 & IEC 62304 translate to development teams
- Experience how to comply in a very efficient and agile way
- Expertise how to bring processes to life with digital tools
Traceability tool to unite processes 100 %
Tools matter! They may block your intentions if they are not designed for the medical industry. It is a strategic choice, whether to think of separate processes OR unite them using a platform. The right tool supports all the needed areas, automates traceability and has electronic signatures complying to FDA 21 CFR PART 11.